Cleared Traditional

K132891 - HYDROLYZED COLLAGEN/AG WOUND GEL WITH S...

K132891 · The Hymed Group Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2014
Decision
276d
Days
-
Risk

K132891 is an FDA 510(k) clearance for the HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by The Hymed Group Corp. (Bethlehem, US). The FDA issued a Cleared decision on June 19, 2014 after a review of 276 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 The Hymed Group Corp. devices

Submission Details

510(k) Number K132891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date June 19, 2014
Days to Decision 276 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
161d slower than avg
Panel avg: 115d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 196
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