CANNULATED DRILL BIT— 510(k) K915692

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K915692 for CANNULATED DRILL BIT, Substantially Equivalent on 1992-01-16. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code HTW
Advisory panel: Orthopedic
Date received: 1991-12-23
Decision date: 1992-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

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.