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510(k) K150551

GORE SEAMGUARD Reinforcement by W.L. Gore & Associates, Inc. — Product Code OXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2015
Date Received
March 4, 2015
Clearance Type
Special
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 W.L. Gore & Associates, Inc.

  • K250410 — GORE® Tri-Lobe Balloon Catheter (June 2, 2025)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
  • K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis (May 8, 2017)

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)
  • K221343 — ECHELON ENDOPATH Staple Line Reinforcement (September 16, 2022)
  • 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)
  • K130997 — NEOVEIL (November 15, 2013)
  • K131658 — GORE SEAMGUARD REINFORCEMENT (September 6, 2013)