CANNULATED DRILL BIT— 510(k) K915692

Name: FDA 510(k) clearance K915692
Creator: U.S. Food and Drug Administration
Published: 1992-01-16

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.. Device class: 1.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code HTW
Device class: Class 1
Regulation: 21 CFR 888.4540
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 ↗

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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.