GDX · Class I · 21 CFR 878.4800

FDA Product Code GDX: Scalpel, One-piece

Leading manufacturers include Abco Dealers, Inc., CooperVision, Inc. and Van-Tec, Inc..

26
Total
26
Cleared
44d
Avg days
1978
Since

FDA 510(k) Cleared Scalpel, One-piece Devices (Product Code GDX)

26 devices
1–24 of 26
Cleared Oct 09, 1991
ICAN CYLINDRICAL SPONGES
K914086
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 28d
Cleared Apr 23, 1991
CCI CORNEAL SCARIFIER
K904505
Buckman Co., Inc.
General & Plastic Surgery · 203d
Cleared Dec 13, 1990
1-CUT ACL GRAFT KNIFE
K905380
Depuy, Inc.
General & Plastic Surgery · 13d
Cleared Jun 20, 1985
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1
K851751
Artiberia
General & Plastic Surgery · 56d
Cleared Jan 27, 1984
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541
Imm Enterprises , Ltd.
General & Plastic Surgery · 67d
Cleared Oct 06, 1982
PILLING DIAMOND KNIFE
K822749
Narco Scientific
General & Plastic Surgery · 26d
Cleared May 05, 1982
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K820869
Van-Tec, Inc.
General & Plastic Surgery · 37d
Cleared Apr 09, 1982
MICRO CISE DIAMOND SCALPEL
K820730
CooperVision, Inc.
General & Plastic Surgery · 23d
Cleared Jan 05, 1982
SCALPEL
K813422
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Feb 13, 1979
STERILE DISPOSABLE KNIFE
K790259
Intermedics, Inc.
General & Plastic Surgery · 7d
Cleared Jul 27, 1978
SCALPEL
K780998
Isolab, Inc.
General & Plastic Surgery · 43d

About Product Code GDX - Regulatory Context