FZX · Class I · 21 CFR 878.4800

FDA Product Code FZX: Guide, Surgical, Instrument

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

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 Aug 18, 1986
A.C.L. GUIDE KIT
K862564
Aspen Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Sep 12, 1984
BRITISH SPINAL FUSION SET
K842698
Downs Surgical , Ltd.
General & Plastic Surgery · 63d
Cleared Apr 25, 1984
TECHMEDICA DRILL GUIDE
K841297
Techmedica, Inc.
General & Plastic Surgery · 26d
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 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