Home / 510(k) Clearances / K152678

510(k) K152678

TYRX Neuro Antibacterial Envelope by Tyrx, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2015
Date Received
September 18, 2015
Clearance Type
Traditional
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 Tyrx, Inc.

  • K132699 — AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) (November 26, 2013)
  • K131007 — AIGIS RX N MEDIUM; AIGIS RX N LARGE (July 10, 2013)
  • K130943 — AIGIS RX R PM/ AIGIS RX R ICD (May 20, 2013)
  • K093524 — PIVIT A/B ST AND PIVIT A/B ST-R (March 26, 2010)

Other clearances for product code FTL

  • K253125 — Parietene™ Flat Sheet Mesh (October 24, 2025)
  • K251955 — Onflex™ Mesh (July 24, 2025)
  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • 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)
  • K232924 — T-Line® Hernia Mesh (October 18, 2023)