meddevicedb.com FDA Device Reference

Magnetic Surgical System

DEN150007 Class II Direct
Decision Date
2016-06-13
Sponsor / Applicant
Levita Magnetics International Corp

Technical Specification

510(k) Submission ID DEN150007
Product Code PNL
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4815
Decision Date 2016-06-13
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Magnetic Surgical System received FDA 510(k) clearance under submission number DEN150007, sponsored by Levita Magnetics International Corp. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2016-06-13.

Classification & Regulation

This clearance is catalogued under FDA product code PNL and 21 CFR 878.4815, within the General, Plastic Surgery review panel as a Class II device.