Cleared Traditional

K193144 - T-Line Hernia Mesh

K193144 is an FDA 510(k) clearance for T-Line Hernia Mesh, manufactured by Deep Blue Medical Advances, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K193144

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 115d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

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 Consultant

Lince Consulting, LLC
Nancy Lince

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 198
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K193144.
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VICRYL Mesh
K191373 · Ethicon, Inc. · Oct 2019