Cleared Traditional

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

Apr 2018
Decision
187d
Days
Risk

K173072 is an FDA 510(k) clearance for the Algidex Ag Silver Alginate Wound Dressing. This device is classified as a Dressing, Wound, Drug.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 4, 2018, 187 days after receiving the submission on September 29, 2017.

This device falls under the General & Plastic Surgery FDA review panel.

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

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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