Cleared Traditional

K123219 - URGOCLEAN ABSORBENT WOUND DRESSING

K123219 · Laboratoires Urgo · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
154d
Days
-
Risk

K123219 is an FDA 510(k) clearance for the URGOCLEAN ABSORBENT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Laboratoires Urgo (Chevigny Saint Sauveur, FR). The FDA issued a Cleared decision on March 18, 2013 after a review of 154 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 - K123219

510(k) Number K123219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date March 18, 2013
Days to Decision 154 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K123219.
LUOFUCON SILVER FOAM DRESSING
K141619 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2015
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
K140954 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2015
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company · Feb 2013
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
K120181 · Huizhou Foryou Medical Devices Co., Ltd. · Feb 2013
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012