CLINICAL NEURO SYSTEMS CRANIAL DRILL— 510(k) K930229

Substantially Equivalent

Clinical Neuro Systems, LLC

FDA 510(k) clearance K930229 for CLINICAL NEURO SYSTEMS CRANIAL DRILL, Substantially Equivalent on 1993-03-16. Applicant: Clinical Neuro Systems, LLC.

Clearance details

Applicant: Clinical Neuro Systems, LLC
Product code: Code HBE
Advisory panel: Neurology
Date received: 1993-01-19
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

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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.