GBS · Class I · 21 CFR 878.4200

FDA Product Code GBS: Catheter, Ventricular, General & Plastic Surgery

Leading manufacturers include Axiom Medical, Inc., Sherwood Medical Co. and C.R. Bard, Inc..

27
Total
27
Cleared
39d
Avg days
1980
Since

FDA 510(k) Cleared Catheter, Ventricular, General & Plastic Surgery Devices (Product Code GBS)

27 devices
1–24 of 27
Cleared Sep 13, 1991
ATRIUMS PDR THORACIC CATHETER
K912645
Atrium Medical Corp.
General & Plastic Surgery · 88d
Cleared May 18, 1988
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873
Sheridan Catheter Corp.
General & Plastic Surgery · 15d
Cleared Mar 14, 1988
URESIL WOUND DRAIN TROCAR
K880895
Uresil Corp.
General & Plastic Surgery · 12d
Cleared Oct 28, 1987
CLOSED CHEST DRAINAGE SET W/SUTURES
K873377
Gish Biomedical, Inc.
General & Plastic Surgery · 65d
Cleared Sep 29, 1986
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560
Uresil Corp.
General & Plastic Surgery · 17d
Cleared Aug 29, 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142
Sheridan Catheter Corp.
General & Plastic Surgery · 14d
Cleared Aug 29, 1986
AXIOM TROCAR THORACIC CATHETER
K863247
Axiom Medical, Inc.
General & Plastic Surgery · 7d
Cleared Aug 12, 1986
OSTEOTOMY DRAINAGE TUBE
K862584
Treace Medical, Inc.
General & Plastic Surgery · 36d
Cleared Aug 07, 1986
SILICONE SUMP DRAIN
K862767
Sil-Med Corp.
General & Plastic Surgery · 16d
Cleared Nov 19, 1985
ROUND SUCTION DRAIN
K854418
Sil-Med Corp.
General & Plastic Surgery · 15d
Cleared Jun 14, 1985
AXIOM ATRAUM TROCAR CATHETER
K852241
Axiom Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jun 05, 1985
CHEST CATHETERS/THORACIC CATHETERS
K851048
Medovations, Inc.
General & Plastic Surgery · 83d
Cleared Oct 31, 1983
AXIOM HYDROMER WOUND DRAINS
K832416
Axiom Medical, Inc.
General & Plastic Surgery · 102d
Cleared Aug 27, 1982
ARGYLE MEDIASTINAL DRAIN
K822318
Sherwood Medical Co.
General & Plastic Surgery · 24d
Cleared Feb 12, 1982
SIL-V-UR CHEST CATHETER
K813463
C.R. Bard, Inc.
General & Plastic Surgery · 63d
Cleared Jan 12, 1982
DISPOSABLE THORACIC CATHETER
K813587
Texas Medical Products, Inc.
General & Plastic Surgery · 15d
Cleared Feb 13, 1981
DAVOL SILICONE SHEATH SUMP DRAIN
K810158
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Oct 23, 1980
ARGYLE SILICONE THORACIC CATHETER
K802318
Sherwood Medical Co.
General & Plastic Surgery · 30d

About Product Code GBS - Regulatory Context