FCO · Box, Battery, Rechargeable
Gastroenterology, Urology · 21 CFR 876.1500 · Class 1
Overview
| Product Code | FCO |
|---|---|
| Device Name | Box, Battery, Rechargeable |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 1 |
| 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 (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K946080 | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | Portable Power Systems, Inc. | Aug 2, 1995 | SESE |
| K945870 | R&D PART NOS. 5490, 5541, 5358, 5497 | R & D Batteries, Inc. | Mar 23, 1995 | SESE |
| K944389 | R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 | R & D Batteries, Inc. | Mar 23, 1995 | SESE |
| K944388 | R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 | R & D Batteries, Inc. | Mar 23, 1995 | SESE |
| K944348 | R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 | R & D Batteries, Inc. | Mar 23, 1995 | SESE |
| K945868 | R&D PART NOS. 5262, 5543, 5432, 5469 | R & D Batteries, Inc. | Mar 6, 1995 | SESE |
| K944521 | RECHARGEABLE BATTERIES | R & D Batteries, Inc. | Mar 6, 1995 | SESE |
| K944387 | R&D BATTERIES PART NOS. 5186 AND 5230 | R & D Batteries, Inc. | Mar 2, 1995 | SESE |
| K945871 | R&D PART NOS. 5339, 5510, 5514 | R & D Batteries, Inc. | Feb 27, 1995 | SESE |
| K945869 | R&D PART NOS. 5443, 5322, 5448, 5492 | R & D Batteries, Inc. | Feb 27, 1995 | SESE |
| K944390 | R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 | R & D Batteries, Inc. | Feb 27, 1995 | SESE |
| K944386 | R&D BATTERIES PART NOS. 5354 AND 5150 | R & D Batteries, Inc. | Dec 30, 1994 | SESE |
| K944294 | R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 | R & D Batteries, Inc. | Dec 30, 1994 | SESE |
| K945867 | R&D PART 5518, 5306, 5315 AND 5457 | R & D Batteries, Inc. | Dec 29, 1994 | SESE |
| K943680 | NCE REPLACEMENT BATTERIES | National Custom Ent., Inc. | Nov 4, 1994 | SESE |
| K943632 | REPLACEMENT BATTERIES | National Custom Ent., Inc. | Nov 4, 1994 | SESE |
| K942018 | R&D BATTERIES, PART NO. 5025, 5128 AND 5183 | R & D Batteries, Inc. | Jul 25, 1994 | SESE |
| K933449 | R AND D BATTERIES, INC. PART NUMBER 5017 | R & D Batteries, Inc. | Mar 1, 1994 | SESE |
| K935472 | R & D BATTERIES, INC. PART NUMBER 5047 | R & D Batteries, Inc. | Feb 25, 1994 | SESE |
| K934683 | R AND D BATERIES | R & D Batteries, Inc. | Nov 22, 1993 | SESE |
Top Applicants
- R & D Batteries, Inc. — 17 clearances
- National Custom Ent., Inc. — 2 clearances
- Portable Power Systems, Inc. — 1 clearance
