K131991 is an FDA 510(k) clearance for the ENDOCHOICE HOT BIOPSY FORCEPS, a Forceps, Biopsy, Electric (Class II — Special Controls, product code KGE), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on October 15, 2013, 109 days after receiving the submission on June 28, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K131991 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 28, 2013 |
| Decision Date | October 15, 2013 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE — Forceps, Biopsy, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |