SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL— 510(k) K001789

Name: FDA 510(k) clearance K001789
Creator: U.S. Food and Drug Administration
Published: 2000-07-06

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K001789 for SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL, Substantially Equivalent on 2000-07-06. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code OXD
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2000-06-13
Decision date: 2000-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OXD

view all

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.