ACRA-CUT XPRESS 120— 510(k) K032970

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K032970 for ACRA-CUT XPRESS 120, Substantially Equivalent on 2003-12-08. Applicant: Acra Cut, Inc..

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBF
Advisory panel: Neurology
Date received: 2003-09-23
Decision date: 2003-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NH, 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.