Cleared Traditional

K040518 - SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING

K040518 · Select Fabricators, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
243d
Days
-
Risk

K040518 is an FDA 510(k) clearance for the SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Select Fabricators, Inc. (Huntington, US). The FDA issued a Cleared decision on October 27, 2004 after a review of 243 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 - K040518

510(k) Number K040518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2004
Decision Date October 27, 2004
Days to Decision 243 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
128d slower than avg
Panel avg: 115d · This submission: 243d
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 K040518.
X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
K033900 · Noble Fiber Technologies · Jan 2005
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
K033732 · Medtrade Products , Ltd. · Dec 2004
3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
COLLAGEN-ORC ANTIMICROBIAL MATRIX
K033523 · Johnson & Johnson Medical, Ltd. · Oct 2004
ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM
K033164 · Dr. Len'S Medical Products, LLC · Sep 2004
SILVER FOAM WOUND DRESSING
K032742 · Advanced Medical Solutions, Ltd. · Aug 2004
K040518 · SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING
Download PDF FDA Summary Select Fabricators, I…