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510(k) K241629

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) by Ethicon Endo-Surgery, LLC — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2024
Date Received
June 6, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stapler, Surgical
Device Class
Class II
Regulation Number
878.4740
Review Panel
SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Other clearances by Ethicon Endo-Surgery, LLC

  • K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (January 9, 2026)
  • 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)
  • K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved (April 13, 2023)
  • K223760 — ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELO (March 15, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)
  • K221343 — ECHELON ENDOPATH Staple Line Reinforcement (September 16, 2022)
  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)

Other clearances for product code GAG

  • K251482 — AEON™ Endoscopic Powered Stapler (July 11, 2025)
  • K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (March 10, 2025)
  • K240881 — Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapte (November 1, 2024)
  • K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (May 7, 2024)
  • K231934 — GIA™ Stapler with Tri-Staple™ Technology (October 27, 2023)
  • K231491 — TA™ Stapler and Loading Unit with DST Series™ Technology (August 16, 2023)
  • K232126 — EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular S (August 16, 2023)
  • K221629 — Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (February 22, 2023)
  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)
  • K970079 — PROXIMATE DISPOSABLE SKIN STAPLER (March 11, 1997)