Cleared Special

T-Line Hernia Mesh (K230227) - FDA 510(k) Clearance

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

K230227 · Deep Blue Medical Advances, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
27d
Days
Class 2
Risk

K230227 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 February 23, 2023 after a review of 27 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 Deep Blue Medical Advances, Inc. devices

Submission Details

510(k) Number K230227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2023
Decision Date February 23, 2023
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 130
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K230227.
Bard 3DMax Mesh
K233402 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Nov 2023
T-Line® Hernia Mesh
K232924 · Deep Blue Medical Advances, Inc. · Oct 2023
Pitch PaSoft Tissue Reinforcement Device
K230671 · Xiros, Ltd. · May 2023
Parietene Macroporous Mesh
K223218 · Sofradim Production · Dec 2022
T-Line Hernia Mesh
K221556 · Deep Blue Medical Advances, Inc. · Nov 2022
ProGrip Self-Gripping Polypropylene Mesh
K220540 · Covidien · Sep 2022