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510(k) K231163

HS Fiber Sutures by Riverpoint Medical — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2024
Date Received
April 24, 2023
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

Other clearances by Riverpoint Medical

  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor (July 30, 2025)
  • K243988 — RootMend MRR (March 20, 2025)
  • K242494 — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct (November 26, 2024)
  • K243323 — Iconix Knotless Anchor (November 19, 2024)
  • K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor (October 29, 2024)
  • K241282 — RibFix Titan™ Fixation System (August 19, 2024)

Other clearances for product code GAT

  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • 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)
  • K230311 — HyperSuture (November 24, 2023)
  • K231183 — Non absorbable Surgical Polyester Suture (August 25, 2023)