K913587 is an FDA 510(k) clearance for the JTECH 50 SERIES CUTTING LOOP, a Resectoscope (Class II — Special Controls, product code FJL), submitted by J-Tech, Inc. (Midvale, US). The FDA issued a Cleared decision on October 23, 1991, 72 days after receiving the submission on August 12, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K913587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 1991 |
| Decision Date | October 23, 1991 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FJL — Resectoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |