K871978 is an FDA 510(k) clearance for the CODMAN FLEXIBLE ENDOSCOPE. This device is classified as a Endoscope, Flexible (Class II - Special Controls, product code GCQ).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on August 25, 1987, 95 days after receiving the submission on May 22, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K871978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1987 |
| Decision Date | August 25, 1987 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GCQ — Endoscope, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |