Cleared Traditional

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (K070420) - FDA 510(k) Clearance

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

K070420 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
27d
Days
Class 2
Risk

K070420 is an FDA 510(k) clearance for the BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 19, 2007 after a review of 27 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 United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K070420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date March 19, 2007
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K070420.
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
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K171989 · Wilson-Cook Medical, Inc. · Mar 2018
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700 · C.R. Bard, Inc. · Apr 1995
DAVOL ERCP CANNULA
K845018 · C.R. Bard, Inc. · Jan 1985