Product Code: GBZ FDA class 1 21 CFR 878.4200

Catheter, Cholangiography

General, Plastic Surgery

The Catheter, Cholangiography (product code GBZ) is a catheter used during surgery to inject contrast media into the bile ducts, enabling radiographic visualization of biliary anatomy and identification of stones or obstructions during cholangiographic examination. It is classified as FDA Class 1, posing minimal risk, subject to general controls only and not requiring 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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FEI Numbers

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Basic Information

Product Code: GBZ
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 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973621	PRE-VIEW CHOLANGIOGRAPHY CLAMP	Dec 17, 1997	Substantially Equivalent	Nashville Surgical Instruments
K944790	FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER	Nov 29, 1994	Substantially Equivalent	Applied Medical Resources
K942450	ENDOPATH	Aug 05, 1994	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K932228	MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER	Aug 10, 1993	Substantially Equivalent	Boston Scientific Corp
K926217	TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE	Jul 13, 1993	Substantially Equivalent	Terumo Medical Corp.
K926143	ANGIOLAPCATH CHOLANGIOGRAPHY KIT	Jul 07, 1993	Unknown	Bd Becton Dickinson Vacutainer Systems Preanalytic
K924212	STRYKER ENDOSCOPY CHOLANGIOGRAM KIT	Jul 07, 1993	Unknown	Stryker Corp.
K925742	CLARUS CHOLANGIOGRAM CATHETER KIT	Jun 01, 1993	Unknown	Clarus Medical Systems, Inc.
K924981	OPERATIVE CHOLANGIOGRAM CATHETER	Apr 06, 1993	Substantially Equivalent	Taut, Inc.
K924480	CHOLANGIOGRAPHY CLAMP	Mar 03, 1993	Substantially Equivalent	Applied Medical Resources
K924128	CHOLANGIOGRAPHY CATHETER	Feb 10, 1993	Substantially Equivalent	Applied Medical Resources
K921091	CHOLANGIOLAPCATH(TM)	May 06, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920643	LAPAROSCOPIC SUCTION/IRRIGATION PROBE	May 06, 1992	Substantially Equivalent	O.R. Concepts, Inc.
K914015	CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP	Nov 21, 1991	Substantially Equivalent	Pilling Co.
K903709	SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH	Oct 26, 1990	Substantially Equivalent	Lifestream Int'L, Inc.
K901520	WURTZ CHOLEY CLIP (TM)	Jun 26, 1990	Substantially Equivalent	Cd Medical, Inc.
K895285	MENTOR DUCTAL CATHETERS	Oct 17, 1989	Substantially Equivalent	Mentor Corp.
K873471	LMI CHOLANGIOGRAM TRAY	Oct 23, 1987	Substantially Equivalent	Lazarus Medical Innovations, Inc.
K870420	PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY	Apr 14, 1987	Unknown	North Coast Medi-Tek
K860534	BILE ENDOPROSTHESIS SET	Mar 10, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K833059	SUCTION CATHETER TRAYS	Dec 12, 1983	Substantially Equivalent	Intermed, Inc.
K831931	ATRIUM THORACIC CATHETER	Oct 04, 1983	Substantially Equivalent	Atrium Medical Corp.
K830711	TRACHESTOMY & NASAL SUCTIONING KIT #-	May 02, 1983	Substantially Equivalent	Intertex Medical
K772288	CATHETER, CHOLANGIOGRAM, OPERATIVE	Jan 30, 1978	Substantially Equivalent	Gesco Intl., Inc.