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510(k) K242679

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) by Fengh Medical Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2024
Date Received
September 6, 2024
Clearance Type
Special
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 Fengh Medical Co., Ltd.

  • K202467 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (December 14, 2020)
  • K182476 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (December 18, 2019)
  • K180208 — Disposable Endoscopic Trocar (April 9, 2018)

Other clearances for product code GDW

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  • 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)
  • K222487 — Anika Tissue Tack Fixation System (May 8, 2023)
  • 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)