Home / 510(k) Clearances / K221343

510(k) K221343

ECHELON ENDOPATH Staple Line Reinforcement by Ethicon Endo-Surgery, LLC — Product Code OXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2022
Date Received
May 9, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

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)
  • K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 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)
  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)

Other clearances for product code OXC

  • K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (January 9, 2026)
  • K231603 — Standard Staple-Line Reinforcement (SSLR23) (October 6, 2023)
  • K221487 — NEOVEIL Staple Line Reinforcement (August 26, 2022)
  • K190937 — Echelon Endopath Staple Line Reinforcement (October 14, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K150551 — GORE SEAMGUARD Reinforcement (March 30, 2015)
  • K130997 — NEOVEIL (November 15, 2013)
  • K131658 — GORE SEAMGUARD REINFORCEMENT (September 6, 2013)