FZX · Class I · 21 CFR 878.4800

FDA Product Code FZX: Guide, Surgical, Instrument

Leading manufacturers include Acufex Microsurgical, Inc., Plastafil, Inc. and Biosearch Medical Products, Inc..

19
Total
19
Cleared
98d
Avg days
1979
Since

FDA 510(k) Cleared Guide, Surgical, Instrument Devices (Product Code FZX)

19 devices
1–19 of 19
Cleared Feb 16, 1994
PARALLELING GUIDES
K914715
Implant Corp. of America
General & Plastic Surgery · 852d
Cleared Jul 14, 1987
CIVCO STEPPER
K871413
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 97d
Cleared Jul 10, 1987
BIOPSY NEEDLE GUIDE KIT, STERILE
K871503
Amedic USA
General & Plastic Surgery · 84d
Cleared Aug 18, 1986
A.C.L. GUIDE KIT
K862564
Aspen Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Dec 24, 1985
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY
K854262
Meadox Surgimed, Inc.
General & Plastic Surgery · 62d
Cleared Jul 11, 1985
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
K852402
North American Instrument Corp.
General & Plastic Surgery · 35d
Cleared Sep 12, 1984
BRITISH SPINAL FUSION SET
K842698
Downs Surgical , Ltd.
General & Plastic Surgery · 63d
Cleared Aug 27, 1984
THREADING TUBE
K841618
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Jul 11, 1984
DRILL GUIDE
K841619
Plastafil, Inc.
General & Plastic Surgery · 83d
Cleared Apr 25, 1984
TECHMEDICA DRILL GUIDE
K841297
Techmedica, Inc.
General & Plastic Surgery · 26d
Cleared Apr 23, 1984
STRAITH DRAIN INSERTER
K840835
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 59d
Cleared Mar 19, 1984
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350
Acufex Microsurgical, Inc.
General & Plastic Surgery · 97d
Cleared Jun 16, 1983
GRAF MENISCAL SUTURE SET
K830720
Acufex Microsurgical, Inc.
General & Plastic Surgery · 100d
Cleared Jun 21, 1982
DISPOSABLE NEEDLE HOLDERS
K821618
Medcare Products
General & Plastic Surgery · 19d
Cleared Apr 23, 1981
BOUNDARY TUBING HOLDERS
K810888
The Buckeye Cellulose Corp.
General & Plastic Surgery · 21d
Cleared Apr 17, 1981
SURGICAL TUBE HOLDER
K810788
The Urology Group
General & Plastic Surgery · 25d
Cleared Sep 26, 1980
GABBAY-FRATER SUTURE GUIDE
K802093
Howmedica Corp.
General & Plastic Surgery · 24d
Cleared Dec 27, 1979
FEEDING TUBE PLACEMENT STYLET
K792468
Biosearch Medical Products, Inc.
General & Plastic Surgery · 24d
Cleared May 23, 1979
ENTERIC TUBE GUIDE
K790872
Biosearch Medical Products, Inc.
General & Plastic Surgery · 16d

About Product Code FZX - Regulatory Context