XK-95 HIGH SPEED MOTOR DRILL SYSTEM— 510(k) K984035

Name: FDA 510(k) clearance K984035
Creator: U.S. Food and Drug Administration
Published: 1999-06-03

Substantially Equivalent

Komet Medical

FDA 510(k) clearance K984035 for XK-95 HIGH SPEED MOTOR DRILL SYSTEM, Substantially Equivalent on 1999-06-03. Applicant: Komet Medical. Device class: 2.

Clearance details

Applicant: Komet Medical
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 1998-11-12
Decision date: 1999-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.