GORE SEAMGUARD REINFORCEMENT— 510(k) K131658

Name: FDA 510(k) clearance K131658
Creator: U.S. Food and Drug Administration
Published: 2013-09-06

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K131658 for GORE SEAMGUARD REINFORCEMENT, Substantially Equivalent on 2013-09-06. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code OXC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-06-06
Decision date: 2013-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OXC

view all

K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)2026-01-09
K231603 — Standard Staple-Line Reinforcement (SSLR23)2023-10-06
K221343 — ECHELON ENDOPATH Staple Line Reinforcement2022-09-16
K221487 — NEOVEIL Staple Line Reinforcement2022-08-26
K190937 — Echelon Endopath Staple Line Reinforcement2019-10-14

More clearances from W. L. Gore & Associates, Inc.

view all

K250410 — GORE® Tri-Lobe Balloon Catheter2025-06-02
K240083 — GORE® PROPATEN® Vascular Graft2024-03-01
K232312 — GORE® PROPATEN® Vascular Graft2024-01-09
K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.