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510(k) K222487

Anika Tissue Tack Fixation System by Anika Therapeutics, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2023
Date Received
August 17, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Anika Therapeutics, Inc.

  • K250997 — Integrity™ Implant (June 17, 2025)
  • K231968 — Tactoset® Injectable Bone Substitute (December 20, 2023)
  • K223538 — Integrity Implant (August 17, 2023)
  • K223860 — Integrity™ Bone Staple Fixation System (May 22, 2023)
  • K223915 — Tactoset (March 29, 2023)
  • K212083 — Tactoset Injectable Bone Substitute (August 31, 2021)
  • K190956 — SCS 17-01 (January 30, 2020)
  • K173008 — SCS 17-01 (December 26, 2017)

Other clearances for product code GDW

  • K252739 — ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapl (December 17, 2025)
  • K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (May 14, 2025)
  • K243276 — ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapl (February 25, 2025)
  • K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (October 28, 2024)
  • K242679 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm (October 4, 2024)
  • K222210 — AEON Endoscopic Stapler (April 21, 2023)
  • K223760 — ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELO (March 15, 2023)
  • K211197 — Disposable Endoscopic Cutter Stapler and Cartridge (January 19, 2023)
  • K221771 — EEA Circular Stapler with Tri-Staple Technology (November 30, 2022)
  • K222641 — Signia™ Small Diameter Reloads Including Regular (Round) Tip Version (November 29, 2022)