Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GBZ — Predicate Candidate Screening

24 FDA 510(k) clearances under this product code; the 50 most recent screened below.

85 daysmedian FDA review time

212 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K973621	PRE-VIEW CHOLANGIOGRAPHY CLAMP	Nashville Surgical Instruments	1997-12-17	85	0
K944790	FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER	Applied Medical Resources	1994-11-29	62	0
K942450	ENDOPATH	Ethicon Endo-Surgery, Inc.	1994-08-05	74	0
K932228	MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER	Boston Scientific Corp	1993-08-10	95	0
K926217	TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE	Terumo Medical Corp.	1993-07-13	215	0
K926143	ANGIOLAPCATH CHOLANGIOGRAPHY KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993-07-07	212	0
K924212	STRYKER ENDOSCOPY CHOLANGIOGRAM KIT	Stryker Corp.	1993-07-07	321	0
K925742	CLARUS CHOLANGIOGRAM CATHETER KIT	Clarus Medical Systems, Inc.	1993-06-01	200	0
K924981	OPERATIVE CHOLANGIOGRAM CATHETER	Taut, Inc.	1993-04-06	187	0
K924480	CHOLANGIOGRAPHY CLAMP	Applied Medical Resources	1993-03-03	181	0
K924128	CHOLANGIOGRAPHY CATHETER	Applied Medical Resources	1993-02-10	177	0
K921091	CHOLANGIOLAPCATH(TM)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-05-06	61	0
K920643	LAPAROSCOPIC SUCTION/IRRIGATION PROBE	O.R. Concepts, Inc.	1992-05-06	84	0
K914015	CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP	Pilling Co.	1991-11-21	73	0
K903709	SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH	Lifestream Int'L, Inc.	1990-10-26	71	0
K901520	WURTZ CHOLEY CLIP (TM)	Cd Medical, Inc.	1990-06-26	85	0
K895285	MENTOR DUCTAL CATHETERS	Mentor Corp.	1989-10-17	54	0
K873471	LMI CHOLANGIOGRAM TRAY	Lazarus Medical Innovations, Inc.	1987-10-23	56	0
K870420	PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY	North Coast Medi-Tek	1987-04-14	70	0
K860534	BILE ENDOPROSTHESIS SET	Angiomed U.S., Inc.	1986-03-10	26	0
K833059	SUCTION CATHETER TRAYS	Intermed, Inc.	1983-12-12	95	0
K831931	ATRIUM THORACIC CATHETER	Atrium Medical Corp.	1983-10-04	111	2
K830711	TRACHESTOMY & NASAL SUCTIONING KIT #-	Intertex Medical	1983-05-02	56	0
K772288	CATHETER, CHOLANGIOGRAM, OPERATIVE	Gesco Intl., Inc.	1978-01-30	49	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda