Product Code: GBX FDA class 1 21 CFR 878.4200

Catheter, Irrigation

General, Plastic Surgery

The Catheter, Irrigation (product code GBX) is a general-purpose catheter used to irrigate wounds, body cavities, or surgical sites by delivering a flow of fluid to clean or flush the area during surgical procedures. It is classified as FDA Class 1, posing minimal risk, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

243

Registration Numbers

243

Unique Applicants

Years Active

Basic Information

Product Code: GBX
Device Class: FDA class 1
Regulation Number: 878.4200
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K131659	MOERAE VEIN PREPARATION KIT	Mar 03, 2014	Substantially Equivalent	Moerae Matrix, Inc.
K082725	GRAFTGUARD PRESSURE CONTROLLING SYRINGE	Dec 17, 2008	Substantially Equivalent	Maquet Cardiovascular, LLC
K052286	DEUTSCH ANTI-BLOCKAGE WOUND DRAIN	Oct 21, 2005	Substantially Equivalent	The Catheter Exchange, Inc.
K043515	GRAFTSAVER	Mar 31, 2005	Substantially Equivalent	Vescare, Inc.
K013417	MISONIX IRRIGATION SYSTEM MOEDL BC20P	Jan 10, 2002	Substantially Equivalent	Misonix, Inc.
K000704	DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)	May 19, 2000	Substantially Equivalent	Dmc Medical, Ltd.
K974233	LYSONIX IRRIGATION SYSTEM	Feb 03, 1998	Substantially Equivalent	Lysonix, Inc.
K973703	JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN	Dec 04, 1997	Substantially Equivalent	Allegiance Healthcare Corp.
K972635	ULTRACELL SUCTION SPONGE	Oct 01, 1997	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K965146	FLAT CLOSED WOUND DRAIN WITH TROCAR	Mar 10, 1997	Substantially Equivalent	Axiom Medical, Inc.
K961295	SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR	Jun 26, 1996	Substantially Equivalent	Sil-Med Corp.
K961147	CLOSED FLUID COLLECTION SYSTEM	May 31, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K960955	JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING	May 22, 1996	Substantially Equivalent	Baxter Healthcare Corp
K955339	HYDROLOGY 5000	Mar 13, 1996	Substantially Equivalent	Northgate Technologies, Inc.
K955474	NEO-PNEUMOCATH	Feb 13, 1996	Substantially Equivalent	Intra Special Catheters GmbH
K955505	OPTI-DRAIN MULTI-USE DRAINAGE CATHETER	Feb 07, 1996	Substantially Equivalent	Navarre Biomedical , Ltd.
K955439	THE REEL THING (MODIFICATION)	Dec 26, 1995	Substantially Equivalent	Biomedical Devices, Inc.
K926496	SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN	May 24, 1995	Substantially Equivalent	Sil-Med Corp.
K951907	NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER	May 15, 1995	Substantially Equivalent	Navarre Biomedical , Ltd.
K951475	NAVARRE UNIVERSAL DRAINAGE CATHETER	Apr 24, 1995	Substantially Equivalent	Navarre Biomedical , Ltd.
K950439	INSYTE SIDEHOLDED DRAINAGE CATHETER	Mar 14, 1995	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K950437	ANGIOCATH SIDEHOLDER DRAINAGE CATHETER	Mar 14, 1995	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K942335	ACI SILICATH THORACIC CATHETER	Aug 09, 1994	Substantially Equivalent	American Catheter
K925243	DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER	Jul 27, 1994	Substantially Equivalent	Deknatel, Inc.
K940156	THE REEL THING	Jun 07, 1994	Substantially Equivalent	Bio-Medical Devices, Inc.
K942274	ORION SUCTION CATHETER KIT WITH STERILE SALINE	Jun 02, 1994	Unknown	Regulatory & Marketing Services, Inc.
K942273	ORION SUCTION CATHETER KIT WITH STERILE WATER	Jun 02, 1994	Unknown	Regulatory & Marketing Services, Inc.
K935531	OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP	May 05, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K940352	STORZ N5941 SERIES MEDICAL GRADE TUBING	Apr 14, 1994	Substantially Equivalent	Storz Instrument Co.
K933600	NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS	Mar 28, 1994	Substantially Equivalent	Navarre Biomedical , Ltd.
K926495	SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE	Feb 02, 1994	Substantially Equivalent	Sil-Med Corp.
K926408	SIL-SLIP FLAT SUCTION DRAIN	Feb 02, 1994	Substantially Equivalent	Sil-Med Corp.
K932391	NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET	Jan 27, 1994	Substantially Equivalent	Navarre Biomedical , Ltd.
K932205	ERCP CATHETER, HYDROPHILIC COATED	Jan 03, 1994	Substantially Equivalent	Wilson-Cook Medical, Inc.
K925117	URESIL ABSCESS DRIANAGE AND IRRIGATION SET	Aug 11, 1993	Substantially Equivalent	Uresil Corp.
K926109	FLUID DRAINAGE TRAY	Jun 07, 1993	Unknown	Symbiosis Corp.
K930551	KENDALL UNIVERSAL EXTENSION SET	May 12, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K923667	IRRIGATION/SUCTION PROBE	Apr 23, 1993	Substantially Equivalent	Surgical Instrument, Inc.
K925176	VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE	Apr 08, 1993	Substantially Equivalent	Boston Scientific Corp
K925805	KENDALL WOUND DRAINAGE SYSTEMS-TROCARS	Feb 26, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K925748	KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN	Jan 13, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K925533	ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET	Jan 12, 1993	Substantially Equivalent	Angeion Corp.
K924702	TURKEL ABDOMINAL PARACENTESIS SYSTEM	Jan 12, 1993	Substantially Equivalent	Symbiosis Corp.
K921424	SIL-MED FLAT SUCTION DRAIN	Sep 28, 1992	Substantially Equivalent	Sil-Med Corp.
K922739	HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE	Aug 06, 1992	Substantially Equivalent	Hollister, Inc.
K921934	INTRADUCER	Jul 15, 1992	Substantially Equivalent	Taut, Inc.
K921095	PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT	Apr 29, 1992	Substantially Equivalent	Pacer Tool & Plastics, Inc.
K913542	THORACIC CATHETER WITH GUIDE	Jan 21, 1992	Substantially Equivalent	Intl. Medical Devices , Ltd.
K913539	THORACIC CATHTER STYLET	Jan 21, 1992	Substantially Equivalent	Intl. Medical Devices , Ltd.
K910245	I/A HANDPIECE WITH REPLACEABLE TIPS	Apr 22, 1991	Substantially Equivalent	Surgical Technologies, Inc.
K905614	JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS	Mar 20, 1991	Substantially Equivalent	Baxter Healthcare Corp
K905766	DRAINAGE TUBE RESTRAINT/WOUND COVER	Mar 06, 1991	Substantially Equivalent	M. Imonti and Associates Inc.,
K905422	PVC ROUND WOUND DRAINS	Feb 11, 1991	Substantially Equivalent	Axiom Medical, Inc.
K904133	DISPOSABLE FLUID COLLECTION BAG	Oct 11, 1990	Substantially Equivalent	Axiom Medical, Inc.
K895756	MIKRO-AQUAPURATOR	Dec 27, 1989	Substantially Equivalent	Mikro-Tek Laboratories
K895755	MIKRO-LAVAGE-1	Dec 27, 1989	Substantially Equivalent	Mikro-Tek Laboratories
K895516	CAVITY DRAINAGE CATHETERIZATION SET, CS-01600	Dec 27, 1989	Substantially Equivalent	Arrow Intl., Inc.
K895757	IRRI-EVACUATOR	Oct 19, 1989	Substantially Equivalent	Mikro-Tek Laboratories
K883474	THORACIC CATHETERS	Sep 13, 1988	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K870704	CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET	Mar 27, 1987	Unknown	American Pharmaseal Div. Ahsc
K844809	CONTINUOUS VENTILATOR	Jun 27, 1985	Substantially Equivalent	Hamilton Medical, Inc.
K852143	HALL IRRIGATION SYSTEM	Jun 26, 1985	Substantially Equivalent	Hall Surgical, Division of Zimmer, Inc.
K844876	PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,	Jun 05, 1985	Substantially Equivalent	Pennine Medical , Ltd.
K844061	MICROTEK IRRIGATION SYSTEM	May 21, 1985	Substantially Equivalent	Microtek Medical, Inc.
K851475	VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5	May 03, 1985	Substantially Equivalent	Vygon Corp.
K844922	PERIMETER THORACIC CATHETER	Mar 18, 1985	Substantially Equivalent	Perimeter Medical, Inc.
K844094	PRUITT IRRIGATION AND OCCLUSION CATHETER	Nov 29, 1984	Substantially Equivalent	Bionomy, Inc.
K843617	SDC SILICONE SUMP DRAIN	Oct 24, 1984	Substantially Equivalent	Science Development Corp.
K841362	TIDAL DISTENSION IRRIGATION SET	Aug 02, 1984	Substantially Equivalent	Abbott Laboratories
K840323	SILICONE SUCTION & IRRIGATION DRAIN	Apr 25, 1984	Substantially Equivalent	Superior Plastic Products Corp.
K830859	I/A KIT	May 02, 1983	Substantially Equivalent	Surgeon Surgical Instrumentation, Inc.
K823496	ARTHROSCOPIC IRRIGATION SETS-2C4030/31	Dec 28, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K822510	SUCTION CATHETER W/STERILE WATER	Oct 13, 1982	Substantially Equivalent	Medine Dynacor
K780788	IRRIGATION CATHETER	Jun 22, 1978	Substantially Equivalent	Shiley, Inc.
K771079	CURITY IRRIGATION TRAY	Sep 15, 1977	Substantially Equivalent	Kendall Research Center
K770706	CATHETER, IRRIGATION	May 06, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K770442	SUMP DRAIN, W/FILTER, ARGYLE EDLICH	Mar 30, 1977	Substantially Equivalent	Sherwood Medical Industries