GDF · Class I · 21 CFR 878.4800

FDA Product Code GDF: Guide, Needle, Surgical

Leading manufacturers include Kinetic Medical Products, Conphar, Inc. and General Electric Co..

28
Total
28
Cleared
83d
Avg days
1982
Since

FDA 510(k) Cleared Guide, Needle, Surgical Devices (Product Code GDF)

28 devices
1–24 of 28
Cleared Mar 15, 1995
SURGICAL INSTRUMENT GUIDE
K950007
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 71d
Cleared May 14, 1992
SIMON BREAST LESION LOCALIZATION NEEDLE
K914941
Manan Medical Products, Inc.
General & Plastic Surgery · 192d
Cleared Apr 21, 1992
PERCUGUIDE LESION MARKING
K920816
E-Z-Em, Inc.
General & Plastic Surgery · 75d
Cleared Nov 21, 1990
ACCUPLACE (TM)
K904172
Dlp, Inc.
General & Plastic Surgery · 71d
Cleared Jan 27, 1989
MICROSURGICAL NEEDLE HOLDERS
K890211
Kinetic Medical Products
General & Plastic Surgery · 9d
Cleared Jan 27, 1989
SURGICAL NEEDLE GUIDE
K890228
Kinetic Medical Products
General & Plastic Surgery · 9d
Cleared Jan 27, 1989
SURGICAL NEEDLE HOLDERS
K890229
Kinetic Medical Products
General & Plastic Surgery · 9d
Cleared Jul 27, 1988
WILLIAMS ACS MARKER NEEDLE
K882036
Buckman Co., Inc.
General & Plastic Surgery · 72d
Cleared Dec 23, 1986
BIOPSY ADAPTER #H4221BG
K864551
General Electric Co.
General & Plastic Surgery · 34d
Cleared Aug 29, 1986
PERCU GUIDE I (LOOP TYPE)
K863090
E-Z-Em, Inc.
General & Plastic Surgery · 16d
Cleared Apr 02, 1986
BIOPSY ADAPTER H4222W
K861050
General Electric Co.
General & Plastic Surgery · 14d
Cleared Jun 03, 1982
MAYO-HEGAR NEEDLE HOLDER
K821289
Conphar, Inc.
General & Plastic Surgery · 30d
Cleared Jun 03, 1982
OLSEN HEGAR NEEDLE HOLDERS
K821295
Conphar, Inc.
General & Plastic Surgery · 30d
Cleared Jun 03, 1982
CONPHAR MAYO HEGAR NEEDLE HOLDER
K821354
Conphar, Inc.
General & Plastic Surgery · 29d

About Product Code GDF - Regulatory Context