Atlas FDA

GBZ

24 FDA 510(k) clearances · Product code

85 daysmedian time to decision
212 days90th percentile
24clearances measured

FDA profile

Official device name
Catheter, Cholangiography
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2015: 12 · 2016: 8 · 2017: 21 · 2018: 51 · 2019: 12 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PRE-VIEW CHOLANGIOGRAPHY CLAMP (K973621)Nashville Surgical Instruments1997-12-17
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (K944790)Applied Medical Resources1994-11-29
ENDOPATH (K942450)Ethicon Endo-Surgery, Inc.1994-08-05
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (K932228)Boston Scientific Corp1993-08-10
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE (K926217)Terumo Medical Corp.1993-07-13
ANGIOLAPCATH CHOLANGIOGRAPHY KIT (K926143)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-07-07
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (K924212)Stryker Corp.1993-07-07
CLARUS CHOLANGIOGRAM CATHETER KIT (K925742)Clarus Medical Systems, Inc.1993-06-01
OPERATIVE CHOLANGIOGRAM CATHETER (K924981)Taut, Inc.1993-04-06
CHOLANGIOGRAPHY CLAMP (K924480)Applied Medical Resources1993-03-03
CHOLANGIOGRAPHY CATHETER (K924128)Applied Medical Resources1993-02-10
CHOLANGIOLAPCATH(TM) (K921091)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-06
LAPAROSCOPIC SUCTION/IRRIGATION PROBE (K920643)O.R. Concepts, Inc.1992-05-06
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (K914015)Pilling Co.1991-11-21
SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH (K903709)Lifestream Int'L, Inc.1990-10-26
WURTZ CHOLEY CLIP (TM) (K901520)Cd Medical, Inc.1990-06-26
MENTOR DUCTAL CATHETERS (K895285)Mentor Corp.1989-10-17
LMI CHOLANGIOGRAM TRAY (K873471)Lazarus Medical Innovations, Inc.1987-10-23
PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY (K870420)North Coast Medi-Tek1987-04-14
BILE ENDOPROSTHESIS SET (K860534)Angiomed U.S., Inc.1986-03-10
SUCTION CATHETER TRAYS (K833059)Intermed, Inc.1983-12-12
ATRIUM THORACIC CATHETER (K831931)Atrium Medical Corp.1983-10-04
TRACHESTOMY & NASAL SUCTIONING KIT #- (K830711)Intertex Medical1983-05-02
CATHETER, CHOLANGIOGRAM, OPERATIVE (K772288)Gesco Intl., Inc.1978-01-30

Track GBZ automatically

Every clearance here is in the API, with alerts when new ones post.