2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP— 510(k) K862689

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K862689 for 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP, Substantially Equivalent on 1986-09-02. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code HXX
Advisory panel: Orthopedic
Date received: 1986-07-15
Decision date: 1986-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code HXX

product code HXX

Injury: 471
Malfunction: 10,945
Total: 11,416

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.