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510(k) K002172

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) by Xiros Plc — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2001
Date Received
July 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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  • K211563 — Pitch-Patchs (August 13, 2021)
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  • K180243 — Infinity-Lock Button System (April 3, 2018)
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  • K151601 — SECURE-LOOP (September 9, 2015)
  • K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (July 13, 2001)

Other clearances for product code GAT

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  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)