Listing a study does not mean it has been evaluated by the u. Thunderbeat hybrid energy urology olympus medical systems. Food and drug administration 9200 corporate boulevard rockville md 20850 may 2 0 2008. Urology pulmonology gynaecology general surgery ear, nose, throat gastroenterology.
Olympus launches five new urology devices, expanding complete. The outpatient imaging platform cv170 allows costeffective access to the power of hd and nbi in endoscopic diagnosis in urology. Compatible for use with olympus brand oes pro series resectoscope compatible for use with wolf brand eline series. Sterile refers to the state of being free from viable microorganisms aami, 2010. Beginning immediately, the olympus urology and stone management sales force will distribute the device to u. This year, olympus celebrates 100 years of making peoples lives healthier, safer and more fulfilling around the world.
The new visera elite ii surgical endoscope system features infrared ir imaging, a subject. The range includes straight channel with angled ocular or angled channel with straight ocular, both with 7o direction of view and 4. Infections associated with reprocessed duodenoscopes fda. Thunderbeat is the worlds first and only advanced energy system that delivers two wellestablished forms of energy to a tissue simultaneously. Launch of visera elite ii surgical endoscope system. Olympus has received fda clearance for the screening and surveillance of barretts esophagus and is currently exploring other claims for. Fda clears olympus narrow band imaging nbi for effective. Equivalent to olympus wa22503dwa22603d 12 medium loop lpo12qfm equivalent to olympus wa22302dwa22602d 30 medium loop lpo30qfm equivalent to olympus wa22306d wa22606d 30 supernoma loop lpo30qfl equivalent to olympus wa22507d wa22607d hemielectrode hemioqf equivalent to olympus wa22557c wa22657c wa22566s. Corp 510k status letter august 12, 2015 pdf 449kb olympus 510k. Thunderbeat is the worlds first and only advanced energy system that delivers two. Enter the product reference number ref, which is located on the label of your olympus medical product into the search field and press search.
The new design provides unsurpassed detail and color reproduction while minimizing operator fatigue. Olympus narrow band imaging for cystoscopy cleared by fda. Urology gynecology business unit ugbu urology field gynecology field flexible and rigid endoscopes ureteroscopes and cystoscopes stone treatment devices disposable flexible hysteroscopes resectoscopes colposcopes the figure for surgical devices net sales. The olympus advantage program is designed to reduce the overall cost of olympus capital products such. This is the only endoscopic light imaging system that helps resolve lesions without dyes or. The portfolio is designed to suit adolescents as well as more difficult anatomies. Olympus offers the optimized solution for outpatient departments.
Lithovue a new scope for every patient boston scientific us. Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today fda. Dec 15, 2014 olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today fda 510k clearance of. Dec 05, 2014 olympus has received fdaclearance for the screening and surveillance of barretts esophagus and is currently exploring other claims for nbi both in gynecology and general surgery. Gastroenterology urology olympus medical systems corp. Jun 08, 2016 the olympus study optimized delivery of mitomycin for primary utuc study olympus the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Urology the oes pro range of singlechannel ureteroscopes is ideal for all aspects of semirigid ureteroscopy urs. To make sure that you use the most recent version of the system guide endoscopy, check our website. Olympus launches five new urology devices, expanding.
Our new surgical imaging platform, visera elite, is equipped with hd imaging capability and advanced image processing to provide the best possible image for. The commitment by olympus to urology is an ongoing pursuit of innovation, constantly aiming to further improve the level of patient care. Olympus has developed an nbi urology app for physicians. Edits made to the original white paper in 2014 are noted in italics. With gamechanging technologies and highend products, we are pioneering and redefining trends and market standards. The olympus study optimized delivery of mitomycin for. Terumo announced on monday that it finalized a basic agreement with fellow japanese devicemaker olympus to expand their u. Cystoscopy urology products olympus medical singapore.
Fda worked closely with fujifilm, olympus, and pentax as they evaluated the sealing. Table of contents urology times issn 00939722 print, issn 21507384 digital is published 12 times a year by multimedia healthcare llc, 230 w superior st, ste 400, duluth mn 55802. Olympus s commitment to urology is an ongoing pursuit of innovation, constantly aiming to further improve levels of patient care. Our new surgical imaging platform, visera elite, is equipped with hd imaging capability and advanced image processing to provide the best possible image for olympus surgical scopes across multiple specialties. Oes pro continuous flow lasercystoscope unique laser control adapter. As a complete urology provider we are active in bph, nmibc, stone management and. The deal stipulates both companies will jointly market urology products in the u. Lisinoprilhydrochlorothiazide prinzide, zestoretic 3. Olympus meets the needs of our urology customers with a family of urology instruments for diagnostic and therapeutic procedures in hospitals, ambulatory surgery centers, and offices. Olympus receives fda clearance for narrow band imaging.
Pediatric cystoscope pediatric urology olympus medical. Drug list by therapeutic category cardiovascular drugs 01. Olympus to distribute terumo glidewire, urologic hydrophilic. Olympus endoscopy surgical instruments endoscopy superstore. Olympus 510k summary evis exera 11 180 system may 2 0 2008 1.
Urology and pelvic health product catalog and ordering information visualization products guidewires. For any other country, visit our companys global website at. You can also improve the search results by setting the filters medical specialty andor language. Prospective randomized trial comparing 2 flexible digital ureteroscopes. With the 4k technology, olympus is now striving to make endoscopic visibility even better than open surgery by adding features such as ultra high definition, wider color gamut, and magnified visualization. Olympus narrow band imaging for cystoscopy cleared by fda december 30th, 2014 medgadget editors urology olympus received clearance from the fda to introduce its narrow band imaging technology in. Yag lasers empowers physicians and hospital systems to meet the diverse surgical challenges they face each day. The olympus study optimized delivery of mitomycin for primary utuc study olympus the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Experience the olympus empower h35 laser for lithotripsy and the olympus empower h65 h100 system that offer additional capabilities for soft tissue and bph treatment.
Food and drug administration 9200 corporate boulevard rockville md 20850 olympus medical systems corp. Olympus has developed an nbi urology app for physicians, available in the app store with the olympus nbi search terms. Olympus is the solution provider for all relevant products used for endoscope reprocessing. In line with all olympus cystoscopes, this compact version still has all the ergonomics and quality that you would. This includes products for manual precleaning brushes and adapters, the olympus washerdisinfector family, and dedicated products for endoscope drying, storage, and. Our complete line of highquality bipolar electrodes are fda validated for use on olympus, storz and. Olympus has a track record of developing and supplying products for endoscopic surgery in its role as a vendor of all forms of endoscopy. Cystoscopy urology products olympus medical systems vietnam. Urology gynaecology general surgery endoeye flex hd 10 mm is a multichip, flexible video laparoscope with a 10 mm distal diameter and provides excellent hd image quality. Explore the benefits and products for general surgery, urology and gynecology. Sterilant refers to a chemical germicide that has been cleared by the fda as capable of destroying all microorganisms, including all bacterial spores rutala et al. Fda 510k applications submitted by olympus america, inc.
Olympus received clearance from the fda to introduce its narrow band imaging technology in the u. Gyrusacmiolympus invisiodurd twelve month failure and repair experience. The glidewire urologic guidewire is considered the gold standard of guidewire offerings, and is an excellent complement to the imaging and therapeutic device solutions of the olympus urology segment. Quentin clemens, md, msci, chair robert dowling, md frances foley, ms, rn, curn howard goldman, md chris gonzalez, md. Pss quickfire bipolar electrodes were developed based on feedback from customers. Olympus compact cystoscope is ideal for paediatric surgery due to its slim design. Olympus introduces five new urology products 20150518. Olympus has received fda clearance for the screening and surveillance of barretts esophagus and is currently exploring other claims for nbi both in gynecology and general surgery. New olympus a3551, a3560, a3550 urological instrument for. Lithotripsy systems urology olympus medical systems. Pss quickfire bipolar electrodes cut costs and reduce procedure times, guaranteed. This page contains information about infections associated with reprocessed duodenoscopes.
Multisociety guideline on reprocessing flexible gastrointestinal. Cystoscopy is one of the most commonly performed procedures in the urology office setting, and is an. The urfv2 features a micromini ccd which enables the outer diameter to be significantly smaller than previousgeneration flexible video ureteroscope 1. Through gamechanging technologies and highend products, we are pioneering and redefining trends and market standards. Food and drug administration 9200 corporate boulevard rockville md. Highresolution hdtv images deliver sharp and clear details, improving observation capabilities when examining mucosal structures and additional. Occupational safety and health administration osha, 2012. Having a long history in supporting physicians needs in stone management through the provision of rigid and flexible ureteroscopes and the related video equipment, olympus is well aware of the additional procedural requirements resulting from the use of singleuse instruments as well as holmium lasers and lithotriptors. System guide endoscopy olympus surgical technologies europe. Spotlights visera elite ii beyond vision a new world of possibilities thunderbeat frontactuated grip type s revolutionary integrated bipolar and ultrasonic surgical instrument with enhanced safety. Pss quickfire bipolar electrodes pss urology pss urology. Olympus offers the optimised solution for outpatient departments. Tur urology products olympus medical systems india. In addition, olympus is pleased to extend its olympus advantage program to the urology market.
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