K232486 is an FDA 510(k) clearance for the KARL STORZ Monopolar Resectoscopes with HF Cable. This device is classified as a Resectoscope (Class II - Special Controls, product code FJL).
Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on May 7, 2024, 265 days after receiving the submission on August 16, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K232486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 265 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 |