Cleared Traditional

K060272 - LOCOBASE WOUND AND SKIN EMULSION

K060272 · Ferndale Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Ferndale Laboratories, Inc. devices

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
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 316
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K060272.
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K053256 · 3M Company · Dec 2005
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K052720 · Medline Industries, Inc. · Oct 2005