Cleared Special

K011178 - WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR

K011178 is an FDA 510(k) clearance for WILSON-COOK THRU-THE-SCOPE MECHANICAL L..., manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LQC cleared through the Special 510(k) pathway after a 17-day FDA review.

K011178 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
17d
Days
Class 2
Risk

K011178 is an FDA 510(k) clearance for the WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR. Classified as Lithotriptor, Biliary Mechanical (product code LQC), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011178

510(k) Number K011178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2001
Decision Date May 04, 2001
Days to Decision 17 days
Submission Type Special
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
114d faster than avg
Panel avg: 131d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

LQC Device Classification - Class 2, Special Controls

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 K011178.
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
GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS
K942544 · Medi-Globe Corp. · Nov 1994
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
K943191 · Boston Scientific Corp · Aug 1994
LAPAROLITH
K905552 · Baxter Healthcare Corp · Dec 1991
SPOON FORCEPS, 11MM
K911364 · Northgate Technologies, Inc. · Oct 1991
K011178 · WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
Download PDF FDA Summary Wilson-Cook Medical, …