GORE SYNECOR Biomaterial— 510(k) K152609

Name: FDA 510(k) clearance K152609
Creator: U.S. Food and Drug Administration
Published: 2015-12-11

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K152609 for GORE SYNECOR Biomaterial, Substantially Equivalent on 2015-12-11. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Product code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2015-09-14
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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K232312 — GORE® PROPATEN® Vascular Graft2024-01-09
K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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