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510(k) K232924

T-Line® Hernia Mesh by Deep Blue Medical Advances, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2023
Date Received
September 19, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Deep Blue Medical Advances, Inc.

  • K230227 — T-Line Hernia Mesh (February 23, 2023)
  • K221556 — T-Line Hernia Mesh (November 28, 2022)
  • K193144 — T-Line Hernia Mesh (March 30, 2020)

Other clearances for product code FTL

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  • K250869 — Parietene™ Macroporous Mesh (PPM5050 ) (April 23, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K243315 — ProGrip™ Self-Gripping Polypropylene Mesh (January 17, 2025)
  • K241250 — 3DMax Light Mesh (June 14, 2024)
  • K232373 — Progrip™ Self-Gripping Polypropylene Mesh (January 18, 2024)
  • K233402 — Bard 3DMax Mesh (November 1, 2023)
  • K230671 — Pitch PaSoft Tissue Reinforcement Device (May 31, 2023)