ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED— 510(k) K911819

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K911819 for ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED, Substantially Equivalent on 1991-09-10. Applicant: Acra Cut, Inc..

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBE
Advisory panel: Neurology
Date received: 1991-04-24
Decision date: 1991-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, 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.