Cleared Traditional

K143017 - Urgoclean Ag

K143017 · Laboratoires Urgo · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
291d
Days
-
Risk

K143017 is an FDA 510(k) clearance for the Urgoclean Ag, Antibacterial Absorbent 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 August 7, 2015 after a review of 291 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 - K143017

510(k) Number K143017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date August 07, 2015
Days to Decision 291 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
176d slower than avg
Panel avg: 115d · This submission: 291d
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 K143017.
Exufiber Ag+
K160379 · Molnlycke Health Care Us, LLC · Aug 2016
LUOFUCON Silicone Ag foam dressing
K160022 · Huizhou Foryou Medical Devices Co., Ltd. · Aug 2016
Medihoney Wound Gel
K150985 · Derma Sciences, Inc. · Nov 2015
MEDIHONEY WOUND DRESSINGS
K133279 · Derma Sciences, Inc. · Jun 2015
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