Cleared Traditional

PHMB Antimicrobial Foam Wound Dressing (K163062) - FDA 510(k) Clearance

K163062 · Advanced Medical Solutions, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
265d
Days
-
Risk

K163062 is an FDA 510(k) clearance for the PHMB Antimicrobial Foam Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions, Ltd. (Winsford, GB). The FDA issued a Cleared decision on July 25, 2017 after a review of 265 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 Advanced Medical Solutions, Ltd. devices

Submission Details

510(k) Number K163062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2016
Decision Date July 25, 2017
Days to Decision 265 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
150d slower than avg
Panel avg: 115d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K163062.
Algidex Ag Silver Alginate Wound Dressing
K173072 · Deroyal Industries, Inc. · Apr 2018
Microcyn Antimicrobial Hydrogel
K173896 · Sonoma Pharmaceuticals, Inc. · Apr 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013