Cleared Traditional

K950700 - BARD BILISYSTEM ENDOSCOPIC RETROGRADE C...

K950700 is the FDA 510(k) clearance for BARD BILISYSTEM ENDOSCOPIC RETROGRADE C... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODD) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K950700 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
71d
Days
Class 2
Risk

K950700 is an FDA 510(k) clearance for the BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 71 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 K950700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date April 27, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
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 9
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K950700.
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · Boston Scientific Corp · Apr 2001
WILSON-COOK STRICTURE MEASURING CATHETER
K973205 · Wilson-Cook Medical, Inc. · Nov 1997
ERCP CANNULA
K963051 · United States Endoscopy Group, Inc. · Mar 1997
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729 · Olympus America, Inc. · Mar 1995
DAVOL ERCP CANNULA
K845018 · C.R. Bard, Inc. · Jan 1985