ODF · Mini Endoscope, Gastroenterology-Urology
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | ODF |
|---|---|
| Device Name | Mini Endoscope, Gastroenterology-Urology |
| 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092739 | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE | C-Link Micro Imaging, Inc. | Jan 12, 2010 | SESE |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | Lumenis, Inc. | Sep 30, 2009 | SESE |
| K090170 | SPYSCOPE ACCESS AND DELIVERY CATHETER | Boston Scientific Corp | Feb 4, 2009 | SESE |
| K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | Boston Scientific Corp | Aug 24, 2005 | SESE |
| K050403 | SPYGLASS DIRECT VISULATION PROBE | Boston Scientific Corp | Mar 4, 2005 | SESE |
| K963354 | 5 STAR MEDICAL ENDOSCOPE | Five Star Medical, Inc. | Sep 8, 1997 | SESE |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Ovamed Corp. | Mar 22, 1995 | SESE |
| K941230 | MINI-UB ENDOSCOPES | Candela Laser Corp. | Jun 17, 1994 | SESE |
| K933106 | ENDOSCOPE | Origin Medsystems, Inc. | Oct 19, 1993 | SESE |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Medical Laser, Inc. | Aug 12, 1991 | SESE |
| K910732 | CANDELA MINI-UB ENDOSCOPE | Candela Laser Corp. | Apr 12, 1991 | SESE |
| K874858 | LASERTRIPTER MINISCOPE | Candela Laser Corp. | Feb 19, 1988 | SESE |
Top Applicants
- Boston Scientific Corp — 3 clearances
- Candela Laser Corp. — 3 clearances
- C-Link Micro Imaging, Inc. — 1 clearance
- Five Star Medical, Inc. — 1 clearance
- Lumenis, Inc. — 1 clearance
