Cleared Traditional

K920361 - BARD BILIARY BALLOON DILATORS

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

K920361 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920361

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
171d slower than avg
Panel avg: 131d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K920361.
INTHERM STASIS VALVE SYSTEM
K931025 · Interventional Therapeutics Corp. · Sep 1993
URESIL BILLIARY CATHETER
K923096 · Uresil Corp. · Jul 1993
ERCP CANNULA
K924107 · United States Endoscopy Group, Inc. · Dec 1992
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K924451 · Interventional Therapeutics Corp. · Oct 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · Cook, Inc. · Jul 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · Cook, Inc. · May 1992