K770906 is an FDA 510(k) clearance for the ANOSCOPE, OPTIC, FIBER. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Welch Allyn, Inc. (Walker, US). The FDA issued a Cleared decision on June 1, 1977, 14 days after receiving the submission on May 18, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Anus And Rectum..
| 510(k) Number | K770906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1977 |
| Decision Date | June 01, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FER — Anoscope And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Anus And Rectum. |