Product Code: KGZ FDA class 1 21 CFR 878.4200

Accessories, Catheter

General, Plastic Surgery

Catheter Accessories are supplementary components and devices used in conjunction with surgical catheters, including connectors, adapters, clamps, and irrigation supplies that support the proper functioning, placement, or management of catheter systems in surgical and clinical settings. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGZ, regulated under 21 CFR 878.4200, within the General, Plastic Surgery medical specialty.

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510(k)s

FEI Numbers

214

Registration Numbers

214

Unique Applicants

Years Active

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Basic Information

Product Code: KGZ
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

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K022306	AART SILICONE TUBING	Oct 10, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K974295	BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING	Feb 10, 1998	Substantially Equivalent	Byron Medical
K973183	WOUND DRAINAGE HOLDER	Jan 23, 1998	Substantially Equivalent	R & D Medical Products, Inc.
K955433	DURALASTIC SILICONE TUBING	Jan 26, 1996	Substantially Equivalent	Allied Biomedical Corp.
K942315	NAVARRE PERCUTANEOUS ACCESS SET	Jul 08, 1994	Substantially Equivalent	Navarre Biomedical , Ltd.
K896087	PALESTRANT IRRIGATION AND DRAINAGE SET	Nov 03, 1989	Substantially Equivalent	North American Instrument Corp.
K895041	OPTICAL CATHETER(TM) INTRODUCER SETS	Oct 16, 1989	Substantially Equivalent	Medical Dynamics, Inc.
K893406	DESERET PRN ADAPTER	Jun 22, 1989	Substantially Equivalent	Deseret Medical, Inc.
K873009	CONCEPT SWITCHING STICK	Aug 17, 1987	Substantially Equivalent	Concept, Inc.
K870014	HCI GENERAL PURPOSE CATHETER STYLET	Feb 06, 1987	Substantially Equivalent	Health Care Innovations, Inc.
K864115	TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU	Nov 07, 1986	Substantially Equivalent	Cathaid, Inc.
K855078	ANGIO MED DISPOSABLE PRESSURE CONNECTORS	Feb 19, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K842666	NU-THOR THORACOSTOMY KIT	Sep 20, 1984	Substantially Equivalent	Intl. Medical Devices , Ltd.
K821525	DESERET UNIVERSAL LUER LOCK	Jun 23, 1982	Substantially Equivalent	Warner-Lambert Co.
K821245	DESERET OFFSET PRN ADAPTER	May 13, 1982	Substantially Equivalent	Warner-Lambert Co.
K810531	PERI-PATCH PERITONEAL CATHETER EXTENSION	Mar 24, 1981	Substantially Equivalent	Quinton, Inc.
K810530	PERI-PATCH GLUE MOLD	Mar 24, 1981	Substantially Equivalent	Quinton, Inc.
K802367	ARROW CATHETER CLAMP	Oct 23, 1980	Substantially Equivalent	Arrow Intl., Inc.
K802286	ARGLE LATEX PENROSE TUBING	Oct 23, 1980	Substantially Equivalent	Sherwood Medical Co.
K791806	CONPHAR ADAPT-CONNECTS STERILE, NONSTE.	Sep 21, 1979	Substantially Equivalent	Conphar, Inc.
K791803	CONPHAR CATHETER PLUG	Sep 21, 1979	Substantially Equivalent	Conphar, Inc.
K790597	SENSOMAT SIDEARM ADAPTER	Jul 10, 1979	Substantially Equivalent	Biochem International, Inc.
K781846	ADAPTER, CATHETER SHEATH	Dec 12, 1978	Substantially Equivalent	Arrow Intl., Inc.
K781854	PAD, B-D I.V. CATH.	Dec 04, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780259	CATHETERIZATION TRAY & KIT	Apr 18, 1978	Substantially Equivalent	Argon Medical Corp.
K770154	3-WAY STOPCOCK WITH LUER-LOCK FITTING	Feb 28, 1977	Substantially Equivalent	American Viggo
K760385	EXTENSION SETS	Nov 02, 1976	Substantially Equivalent	B. Braun Instruments
K760384	STOPPERS	Nov 02, 1976	Substantially Equivalent	B. Braun Instruments
K760383	STOPCOCKS	Nov 02, 1976	Substantially Equivalent	B. Braun Instruments