ACRA-CUT— 510(k) K833266

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K833266 for ACRA-CUT, Substantially Equivalent on 1983-12-29. Applicant: Acra Cut, Inc..

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBF
Advisory panel: Neurology
Date received: 1983-09-21
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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.