Cleared Special

K062147 - INTEGRA SL

K062147 is an FDA 510(k) clearance for INTEGRA SL, manufactured by Direx Systems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Special 510(k) pathway after a 85-day FDA review.

K062147 · Direx Systems Corp. · Gastroenterology & Urology device
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Oct 2006
Decision
85d
Days
Class 2
Risk

K062147 is an FDA 510(k) clearance for the INTEGRA SL. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Direx Systems Corp. (Canton, US). The FDA issued a Cleared decision on October 20, 2006 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - 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.

View all Direx Systems Corp. devices

FDA 510(k) Submission Details - K062147

510(k) Number K062147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date October 20, 2006
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

LNS Device Classification - Class 2, Special Controls

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
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 - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 41
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K062147.
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K042427 · Genemed, Inc. · Dec 2004