Cleared Traditional

K920342 - BARD STONE REMOVAL BALLOON CATHETER

K920342 is the FDA 510(k) clearance for BARD STONE REMOVAL BALLOON CATHETER by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K920342 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
212d
Days
Class 2
Risk

K920342 is an FDA 510(k) clearance for the BARD STONE REMOVAL BALLOON CATHETER. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 212 days - an extended review cycle.

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. Standard predicate reliance. 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 K920342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date August 26, 1992
Days to Decision 212 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
82d slower than avg
Panel avg: 130d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 19
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K920342.
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
K040129 · Wilson-Cook Medical, Inc. · Feb 2004
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
K953951 · Wilson-Cook Medical, Inc. · Sep 1995
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · Boston Scientific Corp · Aug 1993
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · Uresil Corp. · Mar 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · Davol, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
K915506 · United States Endoscopy Group, Inc. · Mar 1992