Cleared Traditional

K160872 - PolyPlex Wound Dressing

K160872 · Global Health Solutions, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
238d
Days
-
Risk

K160872 is an FDA 510(k) clearance for the PolyPlex Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Global Health Solutions, LLC (Rome, US). The FDA issued a Cleared decision on November 23, 2016 after a review of 238 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 Global Health Solutions, LLC devices

FDA 510(k) Submission Details - K160872

510(k) Number K160872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2016
Decision Date November 23, 2016
Days to Decision 238 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
123d slower than avg
Panel avg: 115d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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