Cleared Traditional

K020540 - REGENECARE WOUND GEL

K020540 · Mpm Medical., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K020540

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

SEJ Device Classification - Class 0,

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.

Regulatory Peers - SEJ Wound Dressings Containing Topical Analgesics

Devices cleared under the same product code (SEJ) and FDA review panel - the closest regulatory comparables to K020540.
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025
K092086 · Amerx Health Care Corp. · Jul 2009
ALLWOUND
K053476 · At Squared, LLC · Jun 2006
FREEDOM, MODEL 4660
K001023 · Johnson & Johnson Consumer Companies, Inc. · Sep 2000
HEMO-STAT
K922636 · Mckinley-Ross Laboratories, Inc. · Nov 1992
MICRO-COLL COLLAGEN WOUND SPRAY
K912565 · Micro-Coll · Jun 1992
K020540 · REGENECARE WOUND GEL
Download PDF FDA Summary Mpm Medical., Inc.