K810227 is an FDA 510(k) clearance for the MODEL #53110 DISPOSABLE ANOSCOPE. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981, 23 days after receiving the submission on January 27, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Anus And Rectum..
| 510(k) Number | K810227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1981 |
| Decision Date | February 19, 1981 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| 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. |