Atlas FDA

FBO

19 FDA 510(k) clearances · Product code

127 daysmedian time to decision
379 days90th percentile
19clearances measured

FDA profile

Official device name
Cystourethroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 18 · 2022: 33 · 2023: 29 · 2024: 30 · 2025: 26 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (K244001)Karl Storz SE & CO. KG2025-05-02
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (K243409)Karl Storz SE & CO. KG2024-11-27
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)Laserscope2006-06-27
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
GALILEO ENDOSCOPES (K934649)Galileo Electro-Optics Corp.1994-10-13
KSEA CONTINOUS FLOW CYSTOSCOPE (K943668)KARL STORZ Endoscopy-America, Inc.1994-09-21
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE (K935163)Richard Wolf Medical Instruments Corp.1994-09-07
SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) (K904797)Surgitek1991-03-05
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (K870679)Van-Tec, Inc.1987-03-30
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE (K843084)Olympus Corp.1985-01-03

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Every clearance here is in the API, with alerts when new ones post.