TENSIOMETER— 510(k) K883694

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K883694 for TENSIOMETER, Substantially Equivalent on 1988-11-22. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 1988-08-29
Decision date: 1988-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.