Cleared Traditional

K931619 - MICROVASIVE EXTRACTOR

K931619 is the FDA 510(k) clearance for MICROVASIVE EXTRACTOR by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K931619 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 1993
Decision
140d
Days
Class 2
Risk

K931619 is an FDA 510(k) clearance for the MICROVASIVE EXTRACTOR, RETRIEVAL 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 Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on August 20, 1993 after a review of 140 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 Boston Scientific Corp devices

Submission Details

510(k) Number K931619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date August 20, 1993
Days to Decision 140 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
10d slower than avg
Panel avg: 130d · This submission: 140d
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 K931619.
FUSION QUATTRO EXTRACTION BALLOON XL
K063677 · Wilson-Cook Medical, Inc. · Jan 2007
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
BARD STONE REMOVAL BALLOON CATHETER
K920342 · C.R. Bard, Inc. · Aug 1992
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · Uresil Corp. · Mar 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · Davol, Inc. · Mar 1992