FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE— 510(k) K131364
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K131364 for FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE, Substantially Equivalent on 2014-01-02. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- 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
- Traditional
- Location
- El Segundo, CA, US
Recent devices under product code FBO
view all- K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
- K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
- 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 Endoscopy-America, Inc.
view allRecalls naming K131364
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131364.
Data sourced from openFDA. This site is unofficial and independent of the FDA.