Cleared Traditional

K122297 - ENLUXTRA HUMIFIBER WOUND DRESSING

K122297 · Basf Venture Capital America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
28d
Days
-
Risk

K122297 is an FDA 510(k) clearance for the ENLUXTRA HUMIFIBER WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Basf Venture Capital America, Inc. (Florham Park, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Basf Venture Capital America, Inc. devices

FDA 510(k) Submission Details - K122297

510(k) Number K122297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2012
Decision Date August 28, 2012
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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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