Cleared Traditional

K033164 - ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM

K033164 · Dr. Len'S Medical Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
343d
Days
-
Risk

K033164 is an FDA 510(k) clearance for the ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dr. Len'S Medical Products, LLC (Alpharetta, US). The FDA issued a Cleared decision on September 7, 2004 after a review of 343 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.

FDA 510(k) Submission Details - K033164

510(k) Number K033164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date September 07, 2004
Days to Decision 343 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
228d slower than avg
Panel avg: 115d · This submission: 343d
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 700
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K033164.
3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING
K040518 · Select Fabricators, Inc. · Oct 2004
COLLAGEN-ORC ANTIMICROBIAL MATRIX
K033523 · Johnson & Johnson Medical, Ltd. · Oct 2004
SILVER FOAM WOUND DRESSING
K032742 · Advanced Medical Solutions, Ltd. · Aug 2004
SILVERSEAL
K033587 · Noble Fiber Technologies · Aug 2004
ANTIMICROBIAL ALGINATE DRESSING
K041316 · Advanced Medical Solutions, Ltd. · Aug 2004
K033164 · ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM
Download PDF FDA Summary Dr. Len'S Medical Pro…