Product Code: FBO FDA class 2 21 CFR 876.1500

Cystourethroscope

Gastroenterology, Urology

The Cystourethroscope (product code FBO) is an endoscopic instrument combining the functions of a cystoscope and urethroscope, used to simultaneously examine the urethra and the bladder during a single procedure. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FBO
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

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