Cleared Special

ATRIUM LITE MESH (K002093) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002093 · Atrium Medical Corp. · General & Plastic Surgery device
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Jul 2000
Decision
13d
Days
Class 2
Risk

K002093 is an FDA 510(k) clearance for the ATRIUM LITE MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on July 24, 2000 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

Submission Details

510(k) Number K002093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2000
Decision Date July 24, 2000
Days to Decision 13 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
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 - FTL Mesh, Surgical, Polymeric

All 131
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K002093.
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228 · W.L. Gore & Associates, Inc. · Feb 2001
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672 · Ethicon, Inc. · Nov 2000
COMPOSIX E/X MESH
K002684 · C.R. Bard, Inc. · Oct 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc. · May 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185 · W.L. Gore & Associates, Inc. · Feb 2000
GORE-TEX DUALMESH BIOMATERIAL
K992189 · W.L. Gore & Associates, Inc. · Jul 1999