K993445 is an FDA 510(k) clearance for the OMNISONIC ENDOSCOPIC DEFLECTOR. This device is classified as a Endoscope, Rigid (Class II - Special Controls, product code GCM).
Submitted by Omnisonics Medical Technologies (Hopkonton, US). The FDA issued a Cleared decision on December 6, 1999, 55 days after receiving the submission on October 12, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K993445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1999 |
| Decision Date | December 06, 1999 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCM — Endoscope, Rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |