K100584 is an FDA 510(k) clearance for the EVIS EXERAII 180 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 (Center Valley, US). The FDA issued a Cleared decision on July 2, 2010, 122 days after receiving the submission on March 2, 2010.
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 | K100584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2010 |
| Decision Date | July 02, 2010 |
| Days to Decision | 122 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. |