Cleared Traditional

EPI-MAX (K041059) - FDA 510(k) Clearance

K041059 · Dermagenics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
389d
Days
-
Risk

K041059 is an FDA 510(k) clearance for the EPI-MAX. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dermagenics, Inc. (Memphis, US). The FDA issued a Cleared decision on May 17, 2005 after a review of 389 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Dermagenics, Inc. devices

Submission Details

510(k) Number K041059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date May 17, 2005
Days to Decision 389 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
274d slower than avg
Panel avg: 115d · This submission: 389d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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