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510(k) K220091

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device by Xiros, Ltd. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2022
Date Received
January 12, 2022
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 Xiros, Ltd.

  • K230671 — Pitch PaSoft Tissue Reinforcement Device (May 31, 2023)
  • K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (December 27, 2022)
  • K220906 — SECURE-LOCK (July 22, 2022)
  • K211563 — Pitch-Patchs (August 13, 2021)
  • K191053 — Xtreme-Loop (July 17, 2019)
  • K180243 — Infinity-Lock Button System (April 3, 2018)
  • K171680 — Infinity-Lock 3, Infinity-Lock 5 (June 30, 2017)
  • K151601 — SECURE-LOOP (September 9, 2015)
  • K002172 — POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (August 28, 2001)
  • K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (July 13, 2001)

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)