KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)— 510(k) K243409
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K243409 for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1), Substantially Equivalent on 2024-11-27. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Code FBO
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tuttlingen, DE
Recent devices under product code FBO
view all- K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
- K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
- K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
- K080780 — ANCHORAGE SCOPE, MODEL 000003
- K062918 — KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
More clearances from Karl Storz SE & CO. KG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.