K070913 is an FDA 510(k) clearance for the SELF-LIGHT DISPOSABLE ANOSCOPE, a Anoscope And Accessories (Class II — Special Controls, product code FER), submitted by Sapimed S.P.A. (Crofton, US). The FDA issued a Cleared decision on August 10, 2007, 130 days after receiving the submission on April 2, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K070913 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 2007 |
| Decision Date | August 10, 2007 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |