Cleared Traditional

K062559 - URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER

K062559 · Laboratoires Urgo · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
152d
Days
-
Risk

K062559 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 January 29, 2007 after a review of 152 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Laboratoires Urgo devices

FDA 510(k) Submission Details - K062559

510(k) Number K062559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date January 29, 2007
Days to Decision 152 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 606
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K062559.
RETRO-TECH DRESSING
K060832 · Retro-Tech, LLC · Mar 2007
HEALADEX-P
K063517 · Healagenics, Inc. · Feb 2007
EXSEPT WC WOUND CLEANSER
K061467 · Alcavis International, Inc. · Feb 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · Molnlycke Health Care · Jan 2007
LOCOBASE WOUND AND SKIN EMULSION
K060272 · Ferndale Laboratories, Inc. · Jan 2007
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K061227 · The Hymed Group Corp. · Dec 2006