Cleared Abbreviated

K071552 - PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING

K071552 · Medline Industries, Inc. · General & Plastic Surgery device
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Apr 2008
Decision
324d
Days
-
Risk

K071552 is an FDA 510(k) clearance for the PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 25, 2008 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K071552

510(k) Number K071552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2007
Decision Date April 25, 2008
Days to Decision 324 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 115d · This submission: 324d
Pathway characteristics
Standards-based clearance path.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 708
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K071552 · PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
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