K931763 is an FDA 510(k) clearance for the HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS, a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on August 29, 1994, 508 days after receiving the submission on April 8, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K931763 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 08, 1993 |
| Decision Date | August 29, 1994 |
| Days to Decision | 508 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAS — Electrode, Electrosurgical, Active, Urological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |