Cleared Traditional

K080497 - DERMA SCIENCES CALCIUM ALGINATE DRESSIN...

K080497 · Derma Sciences Canada, Inc. · General & Plastic Surgery device
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Jun 2008
Decision
126d
Days
-
Risk

K080497 is an FDA 510(k) clearance for the DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences Canada, Inc. (Toronto, Orntario, CA). The FDA issued a Cleared decision on June 27, 2008 after a review of 126 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 Derma Sciences Canada, Inc. devices

FDA 510(k) Submission Details - K080497

510(k) Number K080497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2008
Decision Date June 27, 2008
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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