GORE SMOOTHER II AND GORE BPTB— 510(k) K941269

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K941269 for GORE SMOOTHER II AND GORE BPTB, Substantially Equivalent on 1994-05-19. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-03-16
Decision date: 1994-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.