Product Code: KDH FDA class 2 21 CFR 876.5980

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Gastroenterology, Urology

A gastric, colonic, or similar irrigation and aspiration catheter is a flexible hollow tube used to irrigate the gastrointestinal tract or aspirate its contents for diagnostic, therapeutic, or decompressive purposes, including lavage of the stomach, colon, or other gastrointestinal segments. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. Product code KDH is regulated under 21 CFR 876.5980 in the Gastroenterology, Urology medical specialty. This device is eligible for third-party review under FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KDH
Device Class: FDA class 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K983624	GILTECH PLUS CONNECTING TUBE SET	Mar 18, 1999	Substantially Equivalent	Giltech Plus, Inc.
K981286	SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS	Jun 19, 1998	Substantially Equivalent	Armm, Inc.
K971259	COMBIPORT FLUID LAVAGE DEVICE	Oct 27, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K962850	TUM-E-VAC	Feb 21, 1997	Substantially Equivalent	Ethox Corp.
K951533	EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT	Jul 05, 1995	Substantially Equivalent	Ballard Medical Products
K923497	FLUSHING IRRIGATION SET	Mar 21, 1994	Unknown	Orion Life Systems, Inc.
K920619	TRI-MED GASTRIC LAVAGE SYSTEM	Sep 04, 1992	Substantially Equivalent	Tri-Med Specialties, Inc.
K920527	TRI-MED QUICK-STEP GASTRIC LAVAGE KIT	Sep 04, 1992	Substantially Equivalent	Tri-Med Specialties, Inc.
K914908	QUICVAGE PLUS	Apr 13, 1992	Unknown	Autovage
K914907	QUICVAGE	Jan 24, 1992	Substantially Equivalent	Autovage
K911919	MINIVAGE(R)	Jul 26, 1991	Substantially Equivalent	Autovage
K911788	ECONOVAGE R	Jul 26, 1991	Substantially Equivalent	Autovage
K911324	IRRIGATION/ASPIRATION TUBING SET	Jun 24, 1991	Substantially Equivalent	Biomedical Dynamics, Inc.
K902421	STOMACH, GASTRO-ENTEROSTOMY	Nov 20, 1990	Substantially Equivalent	Gainor Medical Europe, Ltd.
K900086	HEMORRHOIDAL LIGATOR WITH SUCTION	Mar 19, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896573	EASI-LAV ADULT GASTRIC LAVAGE KIT	Jan 29, 1990	Substantially Equivalent	Clairson Industries, LLC
K892334	LEONARD TUBE	May 31, 1989	Substantially Equivalent	Surgidyne, Inc.
K860599	ETHOX LAVAGE TUBE	Mar 11, 1986	Substantially Equivalent	Ethox Corp.
K821496	DISPOSABLE IRRIGA/ASPIR. SYSTEM	Jun 22, 1982	Substantially Equivalent	Innovative Surgical Products, Inc.
K781749	TUBING, AXIOM SILICONE PENROSE	Dec 04, 1978	Substantially Equivalent	Axiom Medical, Inc.
K770534	THERAPEUTIC APPARATUS, DIERKER TYPE	Apr 21, 1978	Substantially Equivalent	Well Being Ent.
K770248	ARGYLE RAPID GASTRIC LAVAGE KIT	Mar 09, 1977	Substantially Equivalent	Sherwood Medical Industries
K760556	IRRIGATION CATHETER	Feb 17, 1977	Substantially Equivalent	Sherwood Medical Industries