Atlas FDA

ODD

18 FDA 510(k) clearances · Product code

59 daysmedian time to decision
260 days90th percentile
18clearances measured

FDA profile

Official device name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To identify stones, tumors, or narrowing in the biliary tree.
Adverse events (MAUDE)
2008: 9 · 2009: 26 · 2018: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (K250573)Olympus Medical Systems Corp.2025-05-27
BioShield biopsy valve EUS - Linear (K202583)STERIS Corporation2020-11-06
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter (K171989)Wilson-Cook Medical, Inc.2018-03-20
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (K070420)United States Endoscopy Group, Inc.2007-03-19
DISPOSABLE BENDING CANNULA PR-233Q (K011149)The Olympus Optical Co.2001-05-15
ALIEN RX MICRO CANNULA, MODEL 4530 (K010993)Boston Scientific Corp2001-04-30
WILSON-COOK STRICTURE MEASURING CATHETER (K973205)Wilson-Cook Medical, Inc.1997-11-24
ERCP CANNULA (K963051)United States Endoscopy Group, Inc.1997-03-28
ENDOSCOPIC CATHETER (K953967)Act Medical, Inc.1996-01-22
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA (K950700)C.R. Bard, Inc.1995-04-27
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) (K950729)Olympus America, Inc.1995-03-17
SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM (K910769)Surgitek Medical Engineering Corp.1991-06-25
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (K884709)Primrose Medical, Inc.1989-09-08
DAVOL ERCP CANNULA (K845018)C.R. Bard, Inc.1985-01-15
ERCP CANNULA (K834414)Hobbs Medical, Inc.1984-02-04
ENDOSCOPIC RETROGRADE (K833417)Microvasive1983-11-28
E.R.C.P. CANNULAS (K820431)American Endoscopy, Inc.1982-04-09
E.R.C.P. CANNULA PRODUCT (K802443)Mill-Rose Laboratory1980-10-23

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