KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
FDA 510(k) clearance K243409 · decided 2024-11-27
Clearance details
- K-number
- K243409
- Device name
- KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
- Applicant
- Karl Storz SE & CO. KG
- Decision
- Substantially Equivalent
- Date received
- 2024-11-01
- Decision date
- 2024-11-27
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- FBO
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (K244001) | Karl Storz SE & CO. KG | 2025-05-02 |
| FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (K131364) | KARL STORZ Endoscopy-America, Inc. | 2014-01-02 |
| KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO (K082046) | KARL STORZ Endoscopy-America, Inc. | 2008-10-10 |
| ANCHORAGE SCOPE, MODEL 000003 (K080780) | Epitek, Inc. | 2008-07-30 |
| KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (K062918) | KARL STORZ Endoscopy-America, Inc. | 2007-01-17 |
| LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (K061646) | Laserscope | 2006-06-27 |
| CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 (K011496) | Richard Wolf Medical Instruments Corp. | 2001-08-10 |
| SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM (K972979) | Smith & Nephew, Inc. | 1997-12-11 |
| OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (K962474) | Olympus America, Inc. | 1996-12-20 |
| CYSTOSCOPE (K941992) | Surgical Technologies, Inc. | 1995-11-30 |
| CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS (K951972) | Cabot Medical Corp. | 1995-07-21 |
| CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) (K945185) | KARL STORZ Endoscopy-America, Inc. | 1995-05-03 |
Recalls involving this device
No recalls on record reference this clearance.