Cleared Traditional

K051647 - FORTADERM ANTIMICROBIAL WOUND DRESSING

K051647 · Organogenesis, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2005
Decision
140d
Days
-
Risk

K051647 is an FDA 510(k) clearance for the FORTADERM ANTIMICROBIAL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on November 8, 2005 after a review of 140 days - within the typical 510(k) review window.

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 Organogenesis, Inc. devices

FDA 510(k) Submission Details - K051647

510(k) Number K051647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2005
Decision Date November 08, 2005
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 607
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