FBO · Class II · 21 CFR 876.1500

FDA Product Code FBO: Cystourethroscope

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Richard Wolf Medical Instruments Corp. and Karl Storz SE & CO. KG.

19
Total
19
Cleared
160d
Avg days
1985
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 77d recently vs 170d historically

FDA 510(k) Cleared Cystourethroscope Devices (Product Code FBO)

19 devices
1–19 of 19
Cleared May 02, 2025
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1)
K244001
Karl Storz SE & CO. KG
Gastroenterology & Urology · 127d
Cleared Nov 27, 2024
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
K243409
Karl Storz SE & CO. KG
Gastroenterology & Urology · 26d
Cleared Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 234d
Cleared Oct 10, 2008
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
K082046
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d
Cleared Jan 17, 2007
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 111d
Cleared Jun 27, 2006
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K061646
Laserscope
Gastroenterology & Urology · 15d
Cleared Aug 10, 2001
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660
K011496
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 87d
Cleared Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
K972979
Smith & Nephew, Inc.
Gastroenterology & Urology · 122d
Cleared Dec 20, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
K962474
Olympus America, Inc.
Gastroenterology & Urology · 178d
Cleared Jul 21, 1995
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS
K951972
Cabot Medical Corp.
Gastroenterology & Urology · 85d
Cleared May 03, 1995
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
K945185
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 191d
Cleared Sep 21, 1994
KSEA CONTINOUS FLOW CYSTOSCOPE
K943668
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 55d
Cleared Sep 07, 1994
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE
K935163
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 313d
Cleared Mar 30, 1987
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
K870679
Van-Tec, Inc.
Gastroenterology & Urology · 39d
Cleared Jan 03, 1985
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
K843084
Olympus Corp.
Gastroenterology & Urology · 150d

About Product Code FBO - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code FBO since 1985, with 19 receiving FDA clearance (average review time: 160 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FBO Product Code

Recent submissions under FBO have taken an average of 77 days to reach a decision - down from 170 days historically, suggesting improved FDA processing for this classification.

FBO devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →