Cleared Traditional

UNIVERSAL SURGICAL MESH, MODEL 100 (K070018) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070018 · Generic Medical Device, Inc. · General & Plastic Surgery device
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Apr 2007
Decision
114d
Days
Class 2
Risk

K070018 is an FDA 510(k) clearance for the UNIVERSAL SURGICAL MESH, MODEL 100. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Generic Medical Device, Inc. (Houston, US). The FDA issued a Cleared decision on April 27, 2007 after a review of 114 days - within the typical 510(k) review window.

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 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.

View all Generic Medical Device, Inc. devices

Submission Details

510(k) Number K070018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date April 27, 2007
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 335
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K070018.
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