K102663 is an FDA 510(k) clearance for the AED RESECTOSCOPE, a Resectoscope (Class II — Special Controls, product code FJL), submitted by National Advanced Endoscopy Devices, Inc. (Canoga Park, US). The FDA issued a Cleared decision on December 30, 2010, 106 days after receiving the submission on September 15, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K102663 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 2010 |
| Decision Date | December 30, 2010 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJL — Resectoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |