Cleared Traditional

DAVOL ERCP CANNULA (K845018) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K845018 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jan 1985
Decision
20d
Days
Class 2
Risk

K845018 is an FDA 510(k) clearance for the DAVOL ERCP CANNULA. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on January 15, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K845018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date January 15, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

All 17
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K845018.
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
K250573 · Olympus Medical Systems Corp. · May 2025
BioShield biopsy valve EUS - Linear
K202583 · STERIS Corporation · Nov 2020
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. · Mar 2018
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700 · C.R. Bard, Inc. · Apr 1995