K151191 is an FDA 510(k) clearance for the OES ELITE Telescopes, Protective Tube. This device is classified as a Telescope, Rigid, Endoscopic (Class II - Special Controls, product code FBP).
Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on November 24, 2015, 204 days after receiving the submission on May 4, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K151191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2015 |
| Decision Date | November 24, 2015 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBP — Telescope, Rigid, Endoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |