GEY — Motor, Surgical Instrument, Ac-Powered Class I

FDA Device Classification

Classification Details

Product Code
GEY
Device Class
Class I
Regulation Number
878.4820
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050519linvatecADVANCED TURBO DRIVE SYSTEMMay 17, 2005
K020621arthrocareARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSMarch 28, 2002
K012738depuyacromedSYMPHONY GRAFT DELIVERY SYSTEM (GDS)November 14, 2001
K972308mednextMEDNEXT 1000 DRILLAugust 20, 1997
K971941boyd industriesAQUA SPRAYAugust 14, 1997
K971782biomedical entBONE AND MARROW COLLECTION SYSTEM KITJuly 29, 1997
K971268biomedical internationalBONE & MARROW CLLECTION SYSTEMJuly 3, 1997
K964252buckman coORTHOCHUCKMay 27, 1997
K970530anspach effortANSPACH LUBRICATING SYSTEM IIMay 5, 1997
K964073biomedical entBME BONE DRILL BITSNovember 14, 1996
K962789smith and nephew endoscopySURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEMAugust 14, 1996
K961901biomedical entBONE & MARROW COLLECTION SYSTEMAugust 6, 1996
K954470w.o.m. world of medicineSURGIMOTORDecember 8, 1995
K951773darco intlPODOSPRAY DRILL SYSTEMOctober 26, 1995
K952008karl storz endoscopy-americaKARL STORZ DRILLJuly 26, 1995
K9511183m3M MAXI-DRIVER II ELECTRIC SYSTEMJuly 6, 1995
K940535anspach effortAUTO LUBE SYSTEMMarch 21, 1994
K934172acro-polyACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTSOctober 27, 1993
K932700linvatecCUTO(TM) TISSUE MORCELLATION SYSTEMOctober 15, 1993
K925360elekta instrumentsES-100 POWER SYSTEM, ES-100 SERIESSeptember 7, 1993