Cleared Traditional

K193144 - T-Line Hernia Mesh (FDA 510(k) Clearance)

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

K193144 · Deep Blue Medical Advances, Inc. · General & Plastic Surgery device
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Mar 2020
Decision
138d
Days
Class 2
Risk

K193144 is an FDA 510(k) clearance for the T-Line Hernia Mesh. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Deep Blue Medical Advances, Inc. (Durham, US). The FDA issued a Cleared decision on March 30, 2020 after a review of 138 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 Deep Blue Medical Advances, Inc. devices

Submission Details

510(k) Number K193144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2019
Decision Date March 30, 2020
Days to Decision 138 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
24d slower than avg
Panel avg: 114d · This submission: 138d
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 334
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