Cleared Traditional

K183681 - Protego Antimicrobial Wound Dressing

K183681 · Global Health Solutions (Dba Turn Therapeutics) · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
287d
Days
-
Risk

K183681 is an FDA 510(k) clearance for the Protego Antimicrobial Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Global Health Solutions (Dba Turn Therapeutics) (Calabasas, US). The FDA issued a Cleared decision on October 11, 2019 after a review of 287 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 (Dba Turn Therapeutics) devices

FDA 510(k) Submission Details - K183681

510(k) Number K183681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2018
Decision Date October 11, 2019
Days to Decision 287 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
172d slower than avg
Panel avg: 115d · This submission: 287d
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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