GBX · Class I · 21 CFR 878.4200

FDA Product Code GBX: Catheter, Irrigation

Leading manufacturers include Sil-Med Corp., Axiom Medical, Inc. and Kendall Healthcare Products Co. Div.Of Tyco Health.

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 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 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 May 24, 1995
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
K926496
Sil-Med Corp.
General & Plastic Surgery · 876d
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 Jul 27, 1994
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243
Deknatel, Inc.
General & Plastic Surgery · 649d
Cleared Jun 02, 1994
ORION SUCTION CATHETER KIT WITH STERILE WATER
K942273
Regulatory & Marketing Services, Inc.
General & Plastic Surgery · 23d
Cleared Jun 02, 1994
ORION SUCTION CATHETER KIT WITH STERILE SALINE
K942274
Regulatory & Marketing Services, Inc.
General & Plastic Surgery · 23d
Cleared May 05, 1994
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
K935531
Puritas Health Care, Inc.
General & Plastic Surgery · 170d
Cleared Apr 14, 1994
STORZ N5941 SERIES MEDICAL GRADE TUBING
K940352
Storz Instrument Co.
General & Plastic Surgery · 79d
Cleared Feb 02, 1994
SIL-SLIP FLAT SUCTION DRAIN
K926408
Sil-Med Corp.
General & Plastic Surgery · 408d
Cleared Feb 02, 1994
SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE
K926495
Sil-Med Corp.
General & Plastic Surgery · 400d

About Product Code GBX - Regulatory Context