Cleared Traditional

K943191 - MICROVASIVE MONOLITH(TM) MECHANICAL LIT...

K943191 is the FDA 510(k) clearance for MICROVASIVE MONOLITH(TM) MECHANICAL LIT... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code LQC) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K943191 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
55d
Days
Class 2
Risk

K943191 is an FDA 510(k) clearance for the MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR. Classified as Lithotriptor, Biliary Mechanical (product code LQC), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 29, 1994 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K943191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date August 29, 1994
Days to Decision 55 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
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQC Lithotriptor, Biliary Mechanical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4500
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 - LQC Lithotriptor, Biliary Mechanical

All 8
Devices cleared under the same product code (LQC) and FDA review panel - the closest regulatory comparables to K943191.
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · Boston Scientific Corp · Mar 2004
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
K011178 · Wilson-Cook Medical, Inc. · May 2001
A LITHOTRIPTER-COMPATIBLE BASKET
K964937 · Boston Scientific Corp · Jan 1997
LAPAROLITH
K905552 · Baxter Healthcare Corp · Dec 1991
SPOON FORCEPS, 11MM
K911364 · Northgate Technologies, Inc. · Oct 1991
LAPAROSCOPIC BASKET FLEXIBLE AND RIGID
K911477 · United States Endoscopy Group, Inc. · Aug 1991