Cleared Abbreviated

K041140 - ACELL UBM SURGICAL MESH ML AND MLPLUS

K041140 is an FDA 510(k) clearance for ACELL UBM SURGICAL MESH ML AND MLPLUS, manufactured by Acell, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Abbreviated 510(k) pathway after a 68-day FDA review.

K041140 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jul 2004
Decision
68d
Days
Class 2
Risk

K041140 is an FDA 510(k) clearance for the ACELL UBM SURGICAL MESH ML AND MLPLUS. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Acell, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on July 7, 2004 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Acell, Inc. devices

FDA 510(k) Submission Details - K041140

510(k) Number K041140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date July 07, 2004
Days to Decision 68 days
Submission Type Abbreviated
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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Standards-based clearance path.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTM Mesh, Surgical

All 76
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K041140.
SIS FISTULA PLUG
K050337 · Cook Biotech, Inc. · Mar 2005
BIOBLANKET
K041923 · Kensey Nash Corp. · Sep 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · Implex Corp. · Jul 2004
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K040364 · Porex Surgical, Inc. · Jun 2004
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868 · Genzyme Corp. · Jun 2004
ACELL UBM SURGICAL MESH
K040621 · Acell, Inc. · Apr 2004