K221893 is an FDA 510(k) clearance for the KARL STORZ Bipolar Resectoscopes with HF Cable. This device is classified as a Resectoscope (Class II - Special Controls, product code FJL).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on March 17, 2023, 261 days after receiving the submission on June 29, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K221893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2022 |
| Decision Date | March 17, 2023 |
| Days to Decision | 261 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 |