Cleared Special

K040447 - TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

K040447 is an FDA 510(k) clearance for TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code LQC cleared through the Special 510(k) pathway after a 21-day FDA review.

K040447 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
21d
Days
Class 2
Risk

K040447 is an FDA 510(k) clearance for the TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088. Classified as Lithotriptor, Biliary Mechanical (product code LQC), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 21 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 - K040447

510(k) Number K040447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2004
Decision Date March 12, 2004
Days to Decision 21 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
110d faster than avg
Panel avg: 131d · This submission: 21d
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 K040447.
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
K011178 · Wilson-Cook Medical, Inc. · May 2001
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
K040447 · TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
Download PDF FDA Summary Boston Scientific Corp