Cleared Traditional

K915343 - URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (FDA 510(k) Clearance)

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

K915343 · Uresil Corp. · Gastroenterology & Urology device
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Mar 1992
Decision
126d
Days
Class 2
Risk

K915343 is an FDA 510(k) clearance for the URESIL LAPAROSCOPIC CHOLANGIOGRAPHY 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 Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on March 31, 1992 after a review of 126 days - within the typical 510(k) review window.

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 Uresil Corp. devices

Submission Details

510(k) Number K915343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date March 31, 1992
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 130d · This submission: 126d
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 24
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K915343.
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
K232752 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Feb 2024
SpyGlass Discover Balloon Dilation Catheter
K212582 · Boston Scientific Corporation · May 2022
Stone Retrieval Balloon Catheter
K210660 · Anrei Medical (Hangzhou) Co., Ltd. · Apr 2021