EASYDRILL AUTOSTOP CRANIAL PERFORATOR— 510(k) K141455

Substantially Equivalent

Micromar Ind. Com. , Ltd.

FDA 510(k) clearance K141455 for EASYDRILL AUTOSTOP CRANIAL PERFORATOR, Substantially Equivalent on 2015-03-16. Applicant: Micromar Ind. Com. , Ltd..

Clearance details

Applicant: Micromar Ind. Com. , Ltd.
Product code: Code HBF
Advisory panel: Neurology
Date received: 2014-06-02
Decision date: 2015-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, 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.