Cleared Traditional

K073019 - SILVERMED ANTIMICROBIAL SILVER HYDROGEL

K073019 · Argentis Biomedical Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
327d
Days
-
Risk

K073019 is an FDA 510(k) clearance for the SILVERMED ANTIMICROBIAL SILVER HYDROGEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentis Biomedical Incorporated (Montvale, US). The FDA issued a Cleared decision on September 16, 2008 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Argentis Biomedical Incorporated devices

FDA 510(k) Submission Details - K073019

510(k) Number K073019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date September 16, 2008
Days to Decision 327 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
212d slower than avg
Panel avg: 115d · This submission: 327d
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
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K073019.
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K082330 · Primary Care Solutions, Inc. · Oct 2008
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
K081363 · Advanced Medical Solutions Limited · Sep 2008
ACRYDERM ABSORBENT OXYGEN DRESSING
K082459 · Acrymed, Inc. · Sep 2008
NEOSALUS
K070309 · Quinnova Pharmaceuticals · Sep 2008
SILVER ANTIMICROBIAL WOUND GEL
K073197 · Advanced Medical Solutions Limited · Aug 2008
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
K080497 · Derma Sciences Canada, Inc. · Jun 2008