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EASYDRILL AUTOSTOP CRANIAL PERFORATOR

K141455 Class II Traditional
Decision Date
2015-03-16
Sponsor / Applicant
Micromar Ind. Com. , Ltd.

Technical Specification

510(k) Submission ID K141455
Product Code HBF
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.4305
Decision Date 2015-03-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

EASYDRILL AUTOSTOP CRANIAL PERFORATOR received FDA 510(k) clearance under submission number K141455, sponsored by Micromar Ind. Com. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-03-16.

Classification & Regulation

This clearance is catalogued under FDA product code HBF and 21 CFR 882.4305, within the Neurology review panel as a Class II device.