Cleared Traditional

REGENECARE WOUND GEL (K020540) - FDA 510(k) Clearance

K020540 · Mpm Medical., Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2002
Decision
255d
Days
-
Risk

K020540 is an FDA 510(k) clearance for the REGENECARE WOUND GEL. Classified as Wound Dressings Containing Topical Analgesics (product code SEJ).

Submitted by Mpm Medical., Inc. (Irving, US). The FDA issued a Cleared decision on November 1, 2002 after a review of 255 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

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Submission Details

510(k) Number K020540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date November 01, 2002
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEJ Wound Dressings Containing Topical Analgesics
Device Class -
Definition A Solid Wound Dressing Containing Topical Analgesics Is Used To Cover And Protect A Wound, To Absorb Exudate, To Maintain Appropriate Moisture Balance Within The Wound, And To Reduce Pain. A Wound Dressing Formulated As A Gel, Cream Or Ointment Containing Topical Analgesics Is Used To Maintain Appropriate Moisture Balance Within The Wound And To Reduce Pain.