Cleared Traditional

K060272 - LOCOBASE WOUND AND SKIN EMULSION

K060272 · Ferndale Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
344d
Days
-
Risk

K060272 is an FDA 510(k) clearance for the LOCOBASE WOUND AND SKIN EMULSION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ferndale Laboratories, Inc. (Ferndale, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K060272

510(k) Number K060272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2006
Decision Date January 12, 2007
Days to Decision 344 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
229d slower than avg
Panel avg: 115d · This submission: 344d
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 686
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K060272.
EXSEPT WC WOUND CLEANSER
K061467 · Alcavis International, Inc. · Feb 2007
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · Laboratoires Urgo · Jan 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · Molnlycke Health Care · Jan 2007
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K061227 · The Hymed Group Corp. · Dec 2006
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
K062212 · Anacapa Technologies, Inc. · Nov 2006
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
K063173 · Advanced Medical Solutions Limited · Nov 2006
K060272 · LOCOBASE WOUND AND SKIN EMULSION
Download PDF FDA Summary Ferndale Laboratories…