K093896 is an FDA 510(k) clearance for the ETHICON ENDO SURGERY SLOTTED ANOSCOPE, a Anoscope And Accessories (Class II — Special Controls, product code FER), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 25, 2010, 97 days after receiving the submission on December 18, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K093896 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2009 |
| Decision Date | March 25, 2010 |
| Days to Decision | 97 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. |