Cleared Traditional

K920361 - BARD BILIARY BALLOON DILATORS

K920361 is the FDA 510(k) clearance for BARD BILIARY BALLOON DILATORS by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K920361 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Nov 1992
Decision
302d
Days
Class 2
Risk

K920361 is an FDA 510(k) clearance for the BARD BILIARY BALLOON DILATORS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on November 24, 1992 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K920361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date November 24, 1992
Days to Decision 302 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
172d slower than avg
Panel avg: 130d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K920361.
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994
URESIL BILLIARY CATHETER
K923096 · Uresil Corp. · Jul 1993
ERCP CANNULA
K924107 · United States Endoscopy Group, Inc. · Dec 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · Cook, Inc. · Jul 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · Cook, Inc. · May 1992
ACKRAD ERCP CONTRAST DELIVERY SET
K915813 · Ackrad Laboratories · Mar 1992