K243409 is an FDA 510(k) clearance for the KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1). 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 November 27, 2024, 26 days after receiving the submission on November 1, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K243409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2024 |
| Decision Date | November 27, 2024 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBO — Cystourethroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |