Product Code: GEY FDA class 1 21 CFR 878.4820

Motor, Surgical Instrument, Ac-Powered

General, Plastic Surgery

The Motor, Surgical Instrument, AC-Powered (product code GEY) is an electrically powered drive unit used to operate surgical instrument attachments such as drills, saws, and burrs during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device carries no special flags for implantation, life support, GMP exemption, or third-party review.

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510(k)s

FEI Numbers

151

Registration Numbers

151

Unique Applicants

Years Active

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Basic Information

Product Code: GEY
Device Class: FDA class 1
Regulation Number: 878.4820
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K050519	ADVANCED TURBO DRIVE SYSTEM	May 17, 2005	Substantially Equivalent	Linvatec Corp.
K020621	ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS	Mar 28, 2002	Substantially Equivalent	Arthrocare Corp.
K012738	SYMPHONY GRAFT DELIVERY SYSTEM (GDS)	Nov 14, 2001	Substantially Equivalent	Depuyacromed
K972308	MEDNEXT 1000 DRILL	Aug 20, 1997	Substantially Equivalent	Mednext, Inc.
K971941	AQUA SPRAY	Aug 14, 1997	Substantially Equivalent	Boyd Industries, Inc.
K971782	BONE AND MARROW COLLECTION SYSTEM KIT	Jul 29, 1997	Substantially Equivalent	Biomedical Ent., Inc.
K971268	BONE & MARROW CLLECTION SYSTEM	Jul 03, 1997	Substantially Equivalent	Biomedical International Corp.
K964252	ORTHOCHUCK	May 27, 1997	Substantially Equivalent	Buckman Co., Inc.
K970530	ANSPACH LUBRICATING SYSTEM II	May 05, 1997	Substantially Equivalent	The Anspach Effort, Inc.
K964073	BME BONE DRILL BITS	Nov 14, 1996	Substantially Equivalent	Biomedical Ent., Inc.
K962789	SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM	Aug 14, 1996	Substantially Equivalent	Smith & Nephew Endoscopy, Inc.
K961901	BONE & MARROW COLLECTION SYSTEM	Aug 06, 1996	Substantially Equivalent	Biomedical Ent., Inc.
K954470	SURGIMOTOR	Dec 08, 1995	Substantially Equivalent	W.O.M. World of Medicine GmbH
K951773	PODOSPRAY DRILL SYSTEM	Oct 26, 1995	Substantially Equivalent	Darco Intl., Inc.
K952008	KARL STORZ DRILL	Jul 26, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K951118	3M MAXI-DRIVER II ELECTRIC SYSTEM	Jul 06, 1995	Substantially Equivalent	3M Company
K940535	AUTO LUBE SYSTEM	Mar 21, 1994	Substantially Equivalent	The Anspach Effort, Inc.
K934172	ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS	Oct 27, 1993	Substantially Equivalent	Acro-Poly, Inc.
K932700	CUTO(TM) TISSUE MORCELLATION SYSTEM	Oct 15, 1993	Substantially Equivalent	Linvatec Corp.
K925360	ES-100 POWER SYSTEM, ES-100 SERIES	Sep 07, 1993	Substantially Equivalent	Elekta Instruments, Inc.
K913262	AESCULAP SURGICAL ACCESSORIES	Dec 30, 1991	Substantially Equivalent	Aesculap, Inc.
K913369	MICRO-AIRE MODEL 2060	Nov 01, 1991	Substantially Equivalent	Micro Surgical Instruments Corp.
K913266	MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS	Oct 21, 1991	Substantially Equivalent	Micro Surgical Instruments Corp.
K905383	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	Jun 18, 1991	Substantially Equivalent	Micro Surgical Instruments Corp.
K904682	VISTEK ELECTRONIC CONTROLLER	Dec 18, 1990	Substantially Equivalent	Vistek Corp.
K900033	MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS	Feb 13, 1990	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K882654	PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.	Sep 20, 1988	Substantially Equivalent	Surgical Innovators of America, Inc.
K873476	MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS	Sep 11, 1987	Substantially Equivalent	Mcghan Medical Corp.
K873475	MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS	Sep 11, 1987	Substantially Equivalent	Mcghan Medical Corp.
K853778	THE DEXTRA PRECISION POWER UNIT	Nov 13, 1985	Substantially Equivalent	Storz Instrument Co.
K853762	ISOMETRIC ACL DRILL GUIDE	Oct 07, 1985	Substantially Equivalent	Orthopedic Systems, Inc.
K853761	DRILLING TEMPLATE	Oct 07, 1985	Substantially Equivalent	Orthopedic Systems, Inc.
K850389	MULTIPLE OUTLET MANIFOLD	Mar 18, 1985	Substantially Equivalent	The Anspach Effort, Inc.
K843519	MINUTEMAN CO2 MICROSURG LASER GEN SURG	Dec 07, 1984	Substantially Equivalent	American Surgical Laser, Inc.
K843518	MINUTEMAN C02 MICROSURG LASER PODIATRY	Dec 07, 1984	Substantially Equivalent	American Surgical Laser, Inc.
K843517	MINUTEMAN CO2 MICROSURG LASER DERMATOL-	Dec 07, 1984	Substantially Equivalent	American Surgical Laser, Inc.
K842475	RICHARDS INTRA-ARTICULAR SHAVER MOTOR	Sep 17, 1984	Substantially Equivalent	Richards Medical Co., Inc.
K841165	ELECTRO SURGERY SYSTEM	Jun 05, 1984	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K830153	RICHARDS INTRA-ARTICULAR SHAVER BLADES	Feb 28, 1983	Substantially Equivalent	Richard'S Medical Equip., Inc.
K812438	SAGITTAL SAW	Nov 02, 1981	Substantially Equivalent	Black & Decker(Tm)
K812437	150 DRIVER REAMER	Nov 02, 1981	Substantially Equivalent	Black & Decker(Tm)