WebMay 24, 2024 · LOS ALTOS, Calif., May 24, 2024 /PRNewswire/ -- UroViu Corporation, the developer of a suite of portable, self-contained and versatile single-use cystoscopy solutions, has received clearance from the U.S. Food and Drug Administration to market its third device: Uro-G, a flexible single-use cystoscope with a fully deflectable tip that … WebWiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System: Applicant: OTU Medical INC. 2231 A Fortune Drive: ... U.S. …
Medical device ENDOSCOPES AND - Ambu
WebApr 2, 2024 · A cystoscopy is a procedure to look inside your urethra and bladder using a cystoscope. A cystoscope is a small tube with a light and magnifying camera on the end. ... Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Drugs.com provides accurate and independent information on more … WebThe U.S. Food & Drug Administration recently issued a letter to healthcare providers regarding changes to reprocessing methods for certain urological endoscopes manufactured by Karl Storz, due to infection risk. The letter can be found here. An excerpt follows: “As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient … the lightsenders
Urologic Scopes Recalled Over Contamination Fears
WebApr 7, 2024 · The U.S. Food and Drug Administration is investigating “numerous” medical device reports (MDRs) describing patient infections and other possible contamination issues possibly associated with reprocessed urological endoscopes.. These endoscopes include cystoscopes, ureteroscopes, and cystourethroscopes. Between Jan. 1, 2024 and Feb. … WebDownload .pdf. Simethicone Customer Letter. Download .pdf. Special Notice to Olympus Users of STERRAD Sterilization Systems: Proper Venting of Olympus Fiberoptic/Video Endoscopes using the ETO or Water Resistant Cap. Download .pdf. Sponges for Precleaning Olympus Flexible Endoscopes. Download .pdf. WebDec 9, 2024 · The performance level of Ambu® aScope™ 4 Cysto and aView™ Urologia, compared to current standard practice with re-usable cystoscopes, is defined as proportion of patients with one or more papillary bladder lesion or small resectable lesion (diagnosed a maximum of one month prior to resection) detected with the Ambu® aScope™ 4 Cysto … the lights fest coupon code