AUTOMATIC CRANIAL DRILL (PERFORATOR)— 510(k) K892866

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K892866 for AUTOMATIC CRANIAL DRILL (PERFORATOR), Substantially Equivalent on 1989-06-15. Applicant: Acra Cut, Inc..

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBF
Advisory panel: Neurology
Date received: 1989-04-19
Decision date: 1989-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

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Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.