Cleared Traditional

Silicone PHMB Foam Wound Dressing (K190819) - FDA 510(k) Clearance

K190819 · Advanced Medical Solutions, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
115d
Days
-
Risk

K190819 is an FDA 510(k) clearance for the Silicone PHMB 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, 2019 after a review of 115 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 Advanced Medical Solutions, Ltd. devices

Submission Details

510(k) Number K190819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2019
Decision Date July 25, 2019
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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