meddevicedb.com FDA Device Reference

Edison System

DEN220087 Class II Direct
Decision Date
2023-10-06
Sponsor / Applicant
HistoSonics, Inc.

Technical Specification

510(k) Submission ID DEN220087
Product Code QGM
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4405
Decision Date 2023-10-06
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

Edison System received FDA 510(k) clearance under submission number DEN220087, sponsored by HistoSonics, Inc.. 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 2023-10-06.

Classification & Regulation

This clearance is catalogued under FDA product code QGM and 21 CFR 878.4405, within the General, Plastic Surgery review panel as a Class II device.