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510(k) K211563

Pitch-Patchs by Xiros, Ltd. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2021
Date Received
May 20, 2021
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)
  • K220091 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (August 26, 2022)
  • K220906 — SECURE-LOCK (July 22, 2022)
  • 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)

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