Cleared Special

K061227 - HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER

K061227 · 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
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.

FDA 510(k) Submission Details - K061227

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Modification to existing cleared device.

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 K061227.
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · Laboratoires Urgo · Jan 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · Molnlycke Health Care · Jan 2007
LOCOBASE WOUND AND SKIN EMULSION
K060272 · Ferndale Laboratories, Inc. · Jan 2007
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
K062212 · Anacapa Technologies, Inc. · Nov 2006
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
K063173 · Advanced Medical Solutions Limited · Nov 2006
SINCLAIR SEBORRHEA EMULSION
K050158 · Sinclair Pharmaceuticals, Ltd. · Oct 2006
K061227 · HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
Download PDF FDA Summary The Hymed Group Corp.