K090980 is an FDA 510(k) clearance for the HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L. This device is classified as a Endoscope, Accessories, Narrow Band Spectrum (Class II - Special Controls, product code NWB).
Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on June 29, 2009, 83 days after receiving the submission on April 7, 2009.
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 | K090980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2009 |
| Decision Date | June 29, 2009 |
| Days to Decision | 83 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. |