Cleared Traditional

K132891 - HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER

K132891 · The Hymed Group Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K132891

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 115d · This submission: 276d
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 K132891.
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MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
K133934 · Links Medical Products, Inc. · May 2014
K132891 · HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
Download PDF FDA Summary The Hymed Group Corp.