Cleared Traditional

K160379 - Exufiber Ag+

K160379 · Molnlycke Health Care Us, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
197d
Days
-
Risk

K160379 is an FDA 510(k) clearance for the Exufiber Ag+. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on August 25, 2016 after a review of 197 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 Molnlycke Health Care Us, LLC devices

Submission Details

510(k) Number K160379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2016
Decision Date August 25, 2016
Days to Decision 197 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
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 206
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K160379.
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