PRECLUDE SYNBLOC MEMBRANE— 510(k) K961802

Name: FDA 510(k) clearance K961802
Creator: U.S. Food and Drug Administration
Published: 1996-07-31

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K961802 for PRECLUDE SYNBLOC MEMBRANE, Substantially Equivalent on 1996-07-31. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code GXO
Device class: Class 2
Regulation: 21 CFR 882.5900
Advisory panel: Neurology
Date received: 1996-05-09
Decision date: 1996-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXO

view all

K033395 — CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-12004-02-25

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.