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510(k) K222078

Arthrex SoftStitch by Arthrex, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2022
Date Received
July 14, 2022
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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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)