K926166 is an FDA 510(k) clearance for the COAST VIDEO ENDOSCOPIC IMAGING SYSTEM. This device is classified as a Camera, Television, Endoscopic, Without Audio (Class I - General Controls, product code FWF).
Submitted by Optik (Odenton, US). The FDA issued a Cleared decision on June 1, 1993, 175 days after receiving the submission on December 8, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K926166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1992 |
| Decision Date | June 01, 1993 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FWF — Camera, Television, Endoscopic, Without Audio |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |