Cleared Traditional

HYALOMATRIX PA (K073251) - FDA 510(k) Clearance

K073251 · Fidia Advanced Biopolymers Srl · General & Plastic Surgery device
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Dec 2007
Decision
25d
Days
-
Risk

K073251 is an FDA 510(k) clearance for the HYALOMATRIX PA. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Fidia Advanced Biopolymers Srl (Washington, US). The FDA issued a Cleared decision on December 14, 2007 after a review of 25 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 Fidia Advanced Biopolymers Srl devices

Submission Details

510(k) Number K073251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2007
Decision Date December 14, 2007
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 18
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