Cleared Special

K061227 - HYDROLYZED COLLAGEN/AG WOUND GEL WITH S...

K061227 · The Hymed Group Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
232d
Days
-
Risk

K061227 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 December 20, 2006 after a review of 232 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all The Hymed Group Corp. devices

Submission Details

510(k) Number K061227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date December 20, 2006
Days to Decision 232 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 196
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K061227.
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005