K051645 is an FDA 510(k) clearance for the EVIS EXERA 160A SYSTEM. This device is classified as a Endoscope, Accessories, Narrow Band Spectrum (Class II - Special Controls, product code NWB).
Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on October 13, 2005, 115 days after receiving the submission on June 20, 2005.
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 | K051645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2005 |
| Decision Date | October 13, 2005 |
| Days to Decision | 115 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. |