Cleared Traditional

K171191 - Hexagen Derm

K171191 · Global Health Solutions, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
123d
Days
-
Risk

K171191 is an FDA 510(k) clearance for the Hexagen Derm. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Global Health Solutions, LLC (Rome, US). The FDA issued a Cleared decision on August 25, 2017 after a review of 123 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.

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FDA 510(k) Submission Details - K171191

510(k) Number K171191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2017
Decision Date August 25, 2017
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 242
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K163430 · B.Braun Medical, Inc. · May 2017
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K161623 · B.Braun Medical, Inc. · Nov 2016