GEY · Class I · 21 CFR 878.4820

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

Leading manufacturers include The Anspach Effort, Inc., Biomedical Ent., Inc. and Linvatec Corp..

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 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 15, 1993
CUTO(TM) TISSUE MORCELLATION SYSTEM
K932700
Linvatec Corp.
General & Plastic Surgery · 134d
Cleared Dec 30, 1991
AESCULAP SURGICAL ACCESSORIES
K913262
Aesculap, Inc.
General & Plastic Surgery · 160d
Cleared Feb 13, 1990
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 42d
Cleared Nov 13, 1985
THE DEXTRA PRECISION POWER UNIT
K853778
Storz Instrument Co.
General & Plastic Surgery · 65d
Cleared Oct 07, 1985
DRILLING TEMPLATE
K853761
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Oct 07, 1985
ISOMETRIC ACL DRILL GUIDE
K853762
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Mar 18, 1985
MULTIPLE OUTLET MANIFOLD
K850389
The Anspach Effort, Inc.
General & Plastic Surgery · 45d
Cleared Sep 17, 1984
RICHARDS INTRA-ARTICULAR SHAVER MOTOR
K842475
Richards Medical Co., Inc.
General & Plastic Surgery · 84d

About Product Code GEY - Regulatory Context