GBX · Class I · 21 CFR 878.4200

FDA Product Code GBX: Catheter, Irrigation

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

77
Total
77
Cleared
122d
Avg days
1977
Since
77 devices
25–48 of 77
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 Sep 28, 1992
SIL-MED FLAT SUCTION DRAIN
K921424
Sil-Med Corp.
General & Plastic Surgery · 188d
Cleared Aug 06, 1992
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
K922739
Hollister, Inc.
General & Plastic Surgery · 59d
Cleared Apr 22, 1991
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245
Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Mar 20, 1991
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614
Baxter Healthcare Corp
General & Plastic Surgery · 96d
Cleared Feb 11, 1991
PVC ROUND WOUND DRAINS
K905422
Axiom Medical, Inc.
General & Plastic Surgery · 69d
Cleared Oct 11, 1990
DISPOSABLE FLUID COLLECTION BAG
K904133
Axiom Medical, Inc.
General & Plastic Surgery · 35d
Cleared Dec 27, 1989
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516
Arrow Intl., Inc.
General & Plastic Surgery · 106d
Cleared Sep 13, 1988
THORACIC CATHETERS
K883474
Westmark, Sterile Packing Systems, Inc. (Sps)
General & Plastic Surgery · 28d
Cleared Mar 27, 1987
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 35d
Cleared May 21, 1985
MICROTEK IRRIGATION SYSTEM
K844061
Microtek Medical, Inc.
General & Plastic Surgery · 215d
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