Cleared Traditional

DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) (K080497) - FDA 510(k) Clearance

K080497 · Derma Sciences Canada, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 701
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K080497.
StatSeal Disc
K254073 · Merit Medical Systems, Inc. · May 2026
IWD-Gel™
K254191 · InnovaCorium, Inc. · Apr 2026
MiraChlor Antimicrobial Wound Solution
K252023 · Letus Corporation · Mar 2026
Promogran Prisma™ Collagen Matrix with ORC and Silver
K251999 · Solventum Germany GmbH · Mar 2026
LUOFUCON® Antimicrobial Wound Gel
K252028 · Huizhou Foryou Medical Co., Ltd. · Mar 2026
Redermax Antibacterial Wound Matrix
K251582 · Beijing Kreate Medical Co., Ltd. · Feb 2026