Cleared Traditional

Algidex Ag Silver Alginate Wound Dressing (K173072) - FDA 510(k) Clearance

K173072 · Deroyal Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
187d
Days
-
Risk

K173072 is an FDA 510(k) clearance for the Algidex Ag Silver Alginate Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 4, 2018 after a review of 187 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.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K173072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date April 04, 2018
Days to Decision 187 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
72d slower than avg
Panel avg: 115d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 162
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K173072.
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Microcyn Antimicrobial Hydrogel
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K172338 · Synedgen, Inc. · Feb 2018
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K163430 · B.Braun Medical, Inc. · May 2017