FBO · Cystourethroscope
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FBO |
|---|---|
| Device Name | Cystourethroscope |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & CO. KG | May 2, 2025 | SESE |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | Nov 27, 2024 | SESE |
| K131364 | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | KARL STORZ Endoscopy-America, Inc. | Jan 2, 2014 | SESE |
| K082046 | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO | KARL STORZ Endoscopy-America, Inc. | Oct 10, 2008 | SESE |
| K080780 | ANCHORAGE SCOPE, MODEL 000003 | Epitek, Inc. | Jul 30, 2008 | SESE |
| K062918 | KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | Jan 17, 2007 | SESE |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | Laserscope | Jun 27, 2006 | SESE |
| K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 | Richard Wolf Medical Instruments Corp. | Aug 10, 2001 | SESE |
| K972979 | SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM | Smith & Nephew, Inc. | Dec 11, 1997 | SESE |
| K962474 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) | Olympus America, Inc. | Dec 20, 1996 | SESE |
| K941992 | CYSTOSCOPE | Surgical Technologies, Inc. | Nov 30, 1995 | SESE |
| K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | Cabot Medical Corp. | Jul 21, 1995 | SESE |
| K945185 | CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) | KARL STORZ Endoscopy-America, Inc. | May 3, 1995 | SESE |
| K934649 | GALILEO ENDOSCOPES | Galileo Electro-Optics Corp. | Oct 13, 1994 | SESE |
| K943668 | KSEA CONTINOUS FLOW CYSTOSCOPE | KARL STORZ Endoscopy-America, Inc. | Sep 21, 1994 | SESE |
| K935163 | CONTINUOUS IRRIGATION CYSTOURETHROSCOPE | Richard Wolf Medical Instruments Corp. | Sep 7, 1994 | SESE |
| K904797 | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) | Surgitek | Mar 5, 1991 | SESE |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | Van-Tec, Inc. | Mar 30, 1987 | SESE |
| K843084 | OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE | Olympus Corp. | Jan 3, 1985 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 5 clearances
- Richard Wolf Medical Instruments Corp. — 2 clearances
- Karl Storz SE & CO. KG — 2 clearances
- Van-Tec, Inc. — 1 clearance
- Surgitek — 1 clearance
