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FDA Product Code

FDA Product Code FBO — Clearance Directory

Device Class
Class II
21 CFR Citation
876.1500

510(k) Clearances — 19 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K244001 KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) Karl Storz SE & CO. KG 2025-05-02 Traditional PDF ↗
K243409 KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) Karl Storz SE & CO. KG 2024-11-27 Special PDF ↗
K131364 FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE KARL STORZ Endoscopy-America, Inc. 2014-01-02 Traditional PDF ↗
K082046 KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO KARL STORZ Endoscopy-America, Inc. 2008-10-10 Traditional PDF ↗
K080780 ANCHORAGE SCOPE, MODEL 000003 Epitek, Inc. 2008-07-30 Traditional PDF ↗
K062918 KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM KARL STORZ Endoscopy-America, Inc. 2007-01-17 Traditional PDF ↗
K061646 LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES Laserscope 2006-06-27 Traditional PDF ↗
K011496 CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 Richard Wolf Medical Instruments Corp. 2001-08-10 Traditional PDF ↗
K972979 SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM Smith & Nephew, Inc. 1997-12-11 Traditional PDF ↗
K962474 OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) Olympus America, Inc. 1996-12-20 Traditional PDF ↗
K941992 CYSTOSCOPE Surgical Technologies, Inc. 1995-11-30 Traditional PDF ↗
K951972 CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS Cabot Medical Corp. 1995-07-21 Traditional PDF ↗
K945185 CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) KARL STORZ Endoscopy-America, Inc. 1995-05-03 Traditional PDF ↗
K934649 GALILEO ENDOSCOPES Galileo Electro-Optics Corp. 1994-10-13 Traditional PDF ↗
K943668 KSEA CONTINOUS FLOW CYSTOSCOPE KARL STORZ Endoscopy-America, Inc. 1994-09-21 Traditional PDF ↗
K935163 CONTINUOUS IRRIGATION CYSTOURETHROSCOPE Richard Wolf Medical Instruments Corp. 1994-09-07 Traditional PDF ↗
K904797 SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) Surgitek 1991-03-05 Traditional PDF ↗
K870679 VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE Van-Tec, Inc. 1987-03-30 Traditional PDF ↗
K843084 OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE Olympus Corp. 1985-01-03 Traditional PDF ↗

Product code FBO · Class II · Gastroenterology, Urology. Data: openFDA.