Cleared Traditional

CATHETER WITH INTRODUCER AND SYRINGES (K915129) - FDA 510(k) Clearance

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

K915129 · Utah Pioneer Medical, Inc. · Gastroenterology & Urology device
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Apr 1992
Decision
147d
Days
Class 2
Risk

K915129 is an FDA 510(k) clearance for the CATHETER WITH INTRODUCER AND SYRINGES. 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 Utah Pioneer Medical, Inc. (Orem, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 147 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 Utah Pioneer Medical, Inc. devices

Submission Details

510(k) Number K915129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 13, 1991
Decision Date April 08, 1992
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
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 12
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K915129.
Tri-Ex Extraction Balloon With Multiple Sizing
K170292 · Wilson-Cook Medical, Inc. · Sep 2017
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · Boston Scientific Corp · Aug 1993
BARD STONE REMOVAL BALLOON CATHETER
K920342 · C.R. Bard, Inc. · Aug 1992