K133538 is an FDA 510(k) clearance for the VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE. This device is classified as a Endoscope, Accessories, Narrow Band Spectrum (Class II - Special Controls, product code NWB).
Submitted by Olympus Corporation of the Americas (Center Valley, US). The FDA issued a Cleared decision on August 7, 2014, 262 days after receiving the submission on November 18, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Alternative Mode Of Visualization Using Narrow Bands From The Visible Spectrum For Illumination And Indicated For Endoscopy And Endoscopic Surgery Of The Upper And Lower Diagestive Tract And Urinary Tract..
| 510(k) Number | K133538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2013 |
| Decision Date | August 07, 2014 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NWB — Endoscope, Accessories, Narrow Band Spectrum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Alternative Mode Of Visualization Using Narrow Bands From The Visible Spectrum For Illumination And Indicated For Endoscopy And Endoscopic Surgery Of The Upper And Lower Diagestive Tract And Urinary Tract. |