Cleared Special

K100429 - URGOCELL AG

K100429 · Laboratoires Urgo · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
115d
Days
-
Risk

K100429 is an FDA 510(k) clearance for the URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Laboratoires Urgo (21300 Chenove, FR). The FDA issued a Cleared decision on June 11, 2010 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Laboratoires Urgo devices

FDA 510(k) Submission Details - K100429

510(k) Number K100429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date June 11, 2010
Days to Decision 115 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 239
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