GBX · Class I · 21 CFR 878.4200

FDA Product Code GBX: Catheter, Irrigation

Leading manufacturers include Navarre Biomedical , Ltd., Sil-Med Corp. and Mikro-Tek Laboratories.

77
Total
77
Cleared
122d
Avg days
1977
Since

FDA 510(k) Cleared Catheter, Irrigation Devices (Product Code GBX)

77 devices
1–24 of 77
Cleared Mar 03, 2014
MOERAE VEIN PREPARATION KIT
K131659
Moerae Matrix, Inc.
General & Plastic Surgery · 270d
Cleared Dec 17, 2008
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
K082725
Maquet Cardiovascular, LLC
General & Plastic Surgery · 91d
Cleared Oct 21, 2005
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
K052286
The Catheter Exchange, Inc.
General & Plastic Surgery · 60d
Cleared Mar 31, 2005
GRAFTSAVER
K043515
Vescare, Inc.
General & Plastic Surgery · 101d
Cleared Jan 10, 2002
MISONIX IRRIGATION SYSTEM MOEDL BC20P
K013417
Misonix, Inc.
General & Plastic Surgery · 87d
Cleared May 19, 2000
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
K000704
Dmc Medical, Ltd.
General & Plastic Surgery · 78d
Cleared Feb 03, 1998
LYSONIX IRRIGATION SYSTEM
K974233
Lysonix, Inc.
General & Plastic Surgery · 83d
Cleared Dec 04, 1997
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703
Allegiance Healthcare Corp.
General & Plastic Surgery · 69d
Cleared Oct 01, 1997
ULTRACELL SUCTION SPONGE
K972635
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 79d
Cleared Mar 10, 1997
FLAT CLOSED WOUND DRAIN WITH TROCAR
K965146
Axiom Medical, Inc.
General & Plastic Surgery · 77d
Cleared Jun 26, 1996
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
K961295
Sil-Med Corp.
General & Plastic Surgery · 83d
Cleared May 31, 1996
CLOSED FLUID COLLECTION SYSTEM
K961147
B.Braun Medical, Inc.
General & Plastic Surgery · 71d
Cleared May 22, 1996
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955
Baxter Healthcare Corp
General & Plastic Surgery · 72d
Cleared Mar 13, 1996
HYDROLOGY 5000
K955339
Northgate Technologies, Inc.
General & Plastic Surgery · 114d
Cleared Feb 13, 1996
NEO-PNEUMOCATH
K955474
Intra Special Catheters GmbH
General & Plastic Surgery · 75d
Cleared Feb 07, 1996
OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
K955505
Navarre Biomedical , Ltd.
General & Plastic Surgery · 68d
Cleared Dec 26, 1995
THE REEL THING (MODIFICATION)
K955439
Biomedical Devices, Inc.
General & Plastic Surgery · 43d
Cleared May 24, 1995
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
K926496
Sil-Med Corp.
General & Plastic Surgery · 876d
Cleared May 15, 1995
NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
K951907
Navarre Biomedical , Ltd.
General & Plastic Surgery · 21d
Cleared Apr 24, 1995
NAVARRE UNIVERSAL DRAINAGE CATHETER
K951475
Navarre Biomedical , Ltd.
General & Plastic Surgery · 25d
Cleared Mar 14, 1995
ANGIOCATH SIDEHOLDER DRAINAGE CATHETER
K950437
Becton Dickinson Vascular Access, Inc.
General & Plastic Surgery · 40d
Cleared Mar 14, 1995
INSYTE SIDEHOLDED DRAINAGE CATHETER
K950439
Becton Dickinson Vascular Access, Inc.
General & Plastic Surgery · 40d
Cleared Aug 09, 1994
ACI SILICATH THORACIC CATHETER
K942335
American Catheter
General & Plastic Surgery · 85d
Cleared Jul 27, 1994
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243
Deknatel, Inc.
General & Plastic Surgery · 649d

About Product Code GBX - Regulatory Context