Cleared Traditional

GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (K942544) - FDA 510(k) Clearance

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

K942544 · Medi-Globe Corp. · Gastroenterology & Urology device
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Nov 1994
Decision
175d
Days
Class 2
Risk

K942544 is an FDA 510(k) clearance for the GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS. Classified as Lithotriptor, Biliary Mechanical (product code LQC), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 175 days - an extended review 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: 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 Medi-Globe Corp. devices

Submission Details

510(k) Number K942544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date November 22, 1994
Days to Decision 175 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 130d · This submission: 175d
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 10
Devices cleared under the same product code (LQC) and FDA review panel - the closest regulatory comparables to K942544.
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · Boston Scientific Corp · Mar 2004
A LITHOTRIPTER-COMPATIBLE BASKET
K964937 · Boston Scientific Corp · Jan 1997
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
K943191 · Boston Scientific Corp · Aug 1994
LAPAROLITH
K905552 · Baxter Healthcare Corp · Dec 1991