GEY · Class I · 21 CFR 878.4820

FDA Product Code GEY: Motor, Surgical Instrument, Ac-powered

Leading manufacturers include Biomedical Ent., Inc., American Surgical Laser, Inc. and The Anspach Effort, Inc..

41
Total
41
Cleared
86d
Avg days
1981
Since

FDA 510(k) Cleared Motor, Surgical Instrument, Ac-powered Devices (Product Code GEY)

41 devices
1–24 of 41
Cleared May 17, 2005
ADVANCED TURBO DRIVE SYSTEM
K050519
Linvatec Corp.
General & Plastic Surgery · 77d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER
K020621
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K012738
Depuyacromed
General & Plastic Surgery · 90d
Cleared Aug 20, 1997
MEDNEXT 1000 DRILL
K972308
Mednext, Inc.
General & Plastic Surgery · 61d
Cleared Aug 14, 1997
AQUA SPRAY
K971941
Boyd Industries, Inc.
General & Plastic Surgery · 79d
Cleared Jul 29, 1997
BONE AND MARROW COLLECTION SYSTEM KIT
K971782
Biomedical Ent., Inc.
General & Plastic Surgery · 76d
Cleared Jul 03, 1997
BONE & MARROW CLLECTION SYSTEM
K971268
Biomedical International Corp.
General & Plastic Surgery · 87d
Cleared May 27, 1997
ORTHOCHUCK
K964252
Buckman Co., Inc.
General & Plastic Surgery · 215d
Cleared May 05, 1997
ANSPACH LUBRICATING SYSTEM II
K970530
The Anspach Effort, Inc.
General & Plastic Surgery · 82d
Cleared Nov 14, 1996
BME BONE DRILL BITS
K964073
Biomedical Ent., Inc.
General & Plastic Surgery · 34d
Cleared Aug 14, 1996
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
K962789
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 28d
Cleared Aug 06, 1996
BONE & MARROW COLLECTION SYSTEM
K961901
Biomedical Ent., Inc.
General & Plastic Surgery · 82d
Cleared Dec 08, 1995
SURGIMOTOR
K954470
W.O.M. World of Medicine GmbH
General & Plastic Surgery · 73d
Cleared Oct 26, 1995
PODOSPRAY DRILL SYSTEM
K951773
Darco Intl., Inc.
General & Plastic Surgery · 192d
Cleared Jul 26, 1995
KARL STORZ DRILL
K952008
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 89d
Cleared Jul 06, 1995
3M MAXI-DRIVER II ELECTRIC SYSTEM
K951118
3M Company
General & Plastic Surgery · 118d
Cleared Mar 21, 1994
AUTO LUBE SYSTEM
K940535
The Anspach Effort, Inc.
General & Plastic Surgery · 42d
Cleared Oct 27, 1993
ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS
K934172
Acro-Poly, Inc.
General & Plastic Surgery · 61d
Cleared Oct 15, 1993
CUTO(TM) TISSUE MORCELLATION SYSTEM
K932700
Linvatec Corp.
General & Plastic Surgery · 134d
Cleared Sep 07, 1993
ES-100 POWER SYSTEM, ES-100 SERIES
K925360
Elekta Instruments, Inc.
General & Plastic Surgery · 320d
Cleared Dec 30, 1991
AESCULAP SURGICAL ACCESSORIES
K913262
Aesculap, Inc.
General & Plastic Surgery · 160d
Cleared Nov 01, 1991
MICRO-AIRE MODEL 2060
K913369
Micro Surgical Instruments Corp.
General & Plastic Surgery · 95d
Cleared Oct 21, 1991
MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS
K913266
Micro Surgical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Jun 18, 1991
2710-000 OSCILLATING SAW, GENERAL ASSEMBLY
K905383
Micro Surgical Instruments Corp.
General & Plastic Surgery · 201d

About Product Code GEY - Regulatory Context