GDF · Class I · 21 CFR 878.4800

FDA Product Code GDF: Guide, Needle, Surgical

Leading manufacturers include Conphar, Inc., Kinetic Medical Products 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 Jul 23, 2003
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
K031173
Needle Tech Products, Inc.
General & Plastic Surgery · 100d
Cleared May 26, 1995
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
K950311
Global Medical Products, Ltd.
General & Plastic Surgery · 130d
Cleared Mar 15, 1995
SURGICAL INSTRUMENT GUIDE
K950007
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 71d
Cleared Nov 22, 1994
BREAST LESION LOCALIZATION NEEDLE
K945124
Promex, Inc.
General & Plastic Surgery · 34d
Cleared Nov 04, 1994
BREAST LESION LOCALIZATION NEEDLE
K944942
Promedical , Ltd.
General & Plastic Surgery · 28d
Cleared Feb 22, 1994
BAUER TEMNO COAXIAL NEEDLE
K935538
Bauer Medical, Inc.
General & Plastic Surgery · 98d
Cleared Feb 17, 1994
LOCALIZATION WIRE OR MARKER - SURGICAL
K935457
Bip USA, Inc.
General & Plastic Surgery · 97d
Cleared Jul 13, 1993
NEEDLE-GRABBER
K923840
Guardian Angel Products, Inc.
General & Plastic Surgery · 347d
Cleared Jul 09, 1993
THE ELEVENTH FINGER
K923835
Guardian Angel Products, Inc.
General & Plastic Surgery · 343d
Cleared Apr 06, 1993
HORIZONTAL NEEDLE GUIDE ATTACHMENT
K925875
Bip USA, Inc.
General & Plastic Surgery · 138d
Cleared Sep 23, 1992
BREAST LESION LOCALIZATION NEEDLE
K924270
Core Medical, Inc.
General & Plastic Surgery · 30d
Cleared Sep 01, 1992
MICROGUIDE LESION MARKING SYSTEM
K923120
Angiodynamics, Div. E-Z-Em, Inc.
General & Plastic Surgery · 67d
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 May 03, 1990
KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE
K900903
Milex Products, Inc.
General & Plastic Surgery · 65d
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 Mar 11, 1985
BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT
K845038
Ranfac, Corp.
General & Plastic Surgery · 74d

About Product Code GDF - Regulatory Context