K244001 is an FDA 510(k) clearance for the KARL STORZ Cysto-Urethro-Fiberscope (11272CU1). This device is classified as a Cystourethroscope (Class II - Special Controls, product code FBO).
Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on May 2, 2025, 127 days after receiving the submission on December 26, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K244001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2024 |
| Decision Date | May 02, 2025 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBO — Cystourethroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |