Product Code: FCO FDA class 1 21 CFR 876.1500

Box, Battery, Rechargeable

Gastroenterology, Urology

The Rechargeable Battery Box (product code FCO) is a power supply accessory used to provide rechargeable electrical power to compatible endoscopic or urological instruments. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. 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: FCO
Device Class: FDA class 1
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K946080	PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR	Aug 02, 1995	Substantially Equivalent	Portable Power Systems, Inc.
K945870	R&D PART NOS. 5490, 5541, 5358, 5497	Mar 23, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944389	R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153	Mar 23, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944388	R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100	Mar 23, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944348	R&D BATTERIES, INC. PART NO. 5128, 5053, 5007	Mar 23, 1995	Substantially Equivalent	R & D Batteries, Inc.
K945868	R&D PART NOS. 5262, 5543, 5432, 5469	Mar 06, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944521	RECHARGEABLE BATTERIES	Mar 06, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944387	R&D BATTERIES PART NOS. 5186 AND 5230	Mar 02, 1995	Substantially Equivalent	R & D Batteries, Inc.
K945871	R&D PART NOS. 5339, 5510, 5514	Feb 27, 1995	Substantially Equivalent	R & D Batteries, Inc.
K945869	R&D PART NOS. 5443, 5322, 5448, 5492	Feb 27, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944390	R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277	Feb 27, 1995	Substantially Equivalent	R & D Batteries, Inc.
K944386	R&D BATTERIES PART NOS. 5354 AND 5150	Dec 30, 1994	Substantially Equivalent	R & D Batteries, Inc.
K944294	R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102	Dec 30, 1994	Substantially Equivalent	R & D Batteries, Inc.
K945867	R&D PART 5518, 5306, 5315 AND 5457	Dec 29, 1994	Substantially Equivalent	R & D Batteries, Inc.
K943680	NCE REPLACEMENT BATTERIES	Nov 04, 1994	Substantially Equivalent	National Custom Ent., Inc.
K943632	REPLACEMENT BATTERIES	Nov 04, 1994	Substantially Equivalent	National Custom Ent., Inc.
K942018	R&D BATTERIES, PART NO. 5025, 5128 AND 5183	Jul 25, 1994	Substantially Equivalent	R & D Batteries, Inc.
K933449	R AND D BATTERIES, INC. PART NUMBER 5017	Mar 01, 1994	Substantially Equivalent	R & D Batteries, Inc.
K935472	R & D BATTERIES, INC. PART NUMBER 5047	Feb 25, 1994	Substantially Equivalent	R & D Batteries, Inc.
K934683	R AND D BATERIES	Nov 22, 1993	Substantially Equivalent	R & D Batteries, Inc.