Cleared Traditional

K173549 - BIAFINE

K173549 · Valeant Pharmaceuticals · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2018
Decision
270d
Days
-
Risk

K173549 is an FDA 510(k) clearance for the BIAFINE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Valeant Pharmaceuticals (Rochester, US). The FDA issued a Cleared decision on August 13, 2018 after a review of 270 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 Valeant Pharmaceuticals devices

Submission Details

510(k) Number K173549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2017
Decision Date August 13, 2018
Days to Decision 270 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
155d slower than avg
Panel avg: 115d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 211
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