Cleared Traditional

K063059 - SORBACT WOUND DRESSING

K063059 · Abigo Medical AB · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
196d
Days
-
Risk

K063059 is an FDA 510(k) clearance for the SORBACT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abigo Medical AB (Washington, US). The FDA issued a Cleared decision on April 19, 2007 after a review of 196 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 - K063059

510(k) Number K063059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2006
Decision Date April 19, 2007
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063059.
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
K070333 · Acrymed, Inc. · Jul 2007
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
K063063 · Medical Molecular Therapuetics, LLC · Jul 2007
MP 719
K070557 · Marine Polymer Technologies, Inc. · May 2007
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
K063271 · Convatec, A Division of E.R. Squibb & Sons, LLC · Apr 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · Argentum International, LLC · Mar 2007
K063059 · SORBACT WOUND DRESSING
Download PDF FDA Summary Abigo Medical AB