Cleared Abbreviated

K040621 - ACELL UBM SURGICAL MESH

K040621 is an FDA 510(k) clearance for ACELL UBM SURGICAL MESH, 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 36-day FDA review.

K040621 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
36d
Days
Class 2
Risk

K040621 is an FDA 510(k) clearance for the ACELL UBM SURGICAL MESH. 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 April 14, 2004 after a review of 36 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.

FDA 510(k) Submission Details - K040621

510(k) Number K040621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2004
Decision Date April 14, 2004
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 163
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K040621.
PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
K040835 · Pm Devices, Inc. · Jun 2004
PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
K033985 · Pm Devices, Inc. · Jun 2004
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868 · Genzyme Corp. · Jun 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
K040119 · Synovis Surgical Innovations · Mar 2004
SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc. · Feb 2004
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · DePuy Orthopaedics, Inc. · Jul 2003
K040621 · ACELL UBM SURGICAL MESH
Download PDF FDA Summary Acell, Inc.