Cleared Traditional

K070463 - REVERA WOUND CARE, MODEL MDW0060

K070463 · Revalesio Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
446d
Days
-
Risk

K070463 is an FDA 510(k) clearance for the REVERA WOUND CARE, MODEL MDW0060. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Revalesio Corporation (Tacoma, US). The FDA issued a Cleared decision on May 7, 2008 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K070463

510(k) Number K070463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2007
Decision Date May 07, 2008
Days to Decision 446 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
331d slower than avg
Panel avg: 115d · This submission: 446d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 664
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K070463 · REVERA WOUND CARE, MODEL MDW0060
Download PDF FDA Summary Revalesio Corporation