Cleared Traditional

K090092 - SOCKIT! AND MCMERLIN DERMAL WOUND GEL

K090092 · Mcmerlin Dental Products LP · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
117d
Days
-
Risk

K090092 is an FDA 510(k) clearance for the SOCKIT! AND MCMERLIN DERMAL WOUND GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Mcmerlin Dental Products LP (Grand Prairie, US). The FDA issued a Cleared decision on May 11, 2009 after a review of 117 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K090092

510(k) Number K090092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2009
Decision Date May 11, 2009
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
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 668
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K090092 · SOCKIT! AND MCMERLIN DERMAL WOUND GEL
Download PDF FDA Summary Mcmerlin Dental Produ…