GBX · Class I · 21 CFR 878.4200

FDA Product Code GBX: Catheter, Irrigation

Leading manufacturers include Kendall Healthcare Products Co. Div.Of Tyco Health, Baxter Healthcare Corp and Symbiosis Corp..

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 Dec 04, 1997
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703
Allegiance Healthcare Corp.
General & Plastic Surgery · 69d
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 Jul 27, 1994
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243
Deknatel, Inc.
General & Plastic Surgery · 649d
Cleared Apr 14, 1994
STORZ N5941 SERIES MEDICAL GRADE TUBING
K940352
Storz Instrument Co.
General & Plastic Surgery · 79d
Cleared Jan 03, 1994
ERCP CATHETER, HYDROPHILIC COATED
K932205
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 242d
Cleared Aug 11, 1993
URESIL ABSCESS DRIANAGE AND IRRIGATION SET
K925117
Uresil Corp.
General & Plastic Surgery · 306d
Cleared Jun 07, 1993
FLUID DRAINAGE TRAY
K926109
Symbiosis Corp.
General & Plastic Surgery · 186d
Cleared May 12, 1993
KENDALL UNIVERSAL EXTENSION SET
K930551
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 98d
Cleared Apr 08, 1993
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176
Boston Scientific Corp
General & Plastic Surgery · 176d
Cleared Feb 26, 1993
KENDALL WOUND DRAINAGE SYSTEMS-TROCARS
K925805
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 102d
Cleared Jan 13, 1993
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 61d
Cleared Jan 12, 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702
Symbiosis Corp.
General & Plastic Surgery · 117d
Cleared Aug 06, 1992
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
K922739
Hollister, Inc.
General & Plastic Surgery · 59d
Cleared Mar 20, 1991
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614
Baxter Healthcare Corp
General & Plastic Surgery · 96d
Cleared Dec 27, 1989
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516
Arrow Intl., Inc.
General & Plastic Surgery · 106d
Cleared Mar 27, 1987
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 35d
Cleared May 03, 1985
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475
Vygon Corp.
General & Plastic Surgery · 18d
Cleared Aug 02, 1984
TIDAL DISTENSION IRRIGATION SET
K841362
Abbott Laboratories
General & Plastic Surgery · 122d
Cleared Dec 28, 1982
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496
Travenol Laboratories, S.A.
General & Plastic Surgery · 35d
Cleared Jun 22, 1978
IRRIGATION CATHETER
K780788
Shiley, Inc.
General & Plastic Surgery · 38d
Cleared May 06, 1977
CATHETER, IRRIGATION
K770706
Mallinckrodt Critical Care
General & Plastic Surgery · 18d
Cleared Mar 30, 1977
SUMP DRAIN, W/FILTER, ARGYLE EDLICH
K770442
Sherwood Medical Industries
General & Plastic Surgery · 23d

About Product Code GBX - Regulatory Context