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510(k) K131658

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

K131658 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE SEAMGUARD REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on September 6, 2013. The device falls under product code OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2013
Date Received
June 6, 2013
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 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)
  • K222919 — GORE® ENFORM Biomaterial (December 19, 2022)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K180919 — GORE Tri-Lumen Catheter (October 5, 2018)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)

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)
  • K150551 — GORE SEAMGUARD Reinforcement (March 30, 2015)
  • K130997 — NEOVEIL (November 15, 2013)

FDA data resources