FDA 510(k) Application Details - K212871

Device Classification Name	Low Energy Direct Current Thermal Ablation System   More FDA Info for this Device
510(K) Number	K212871
Device Name	Low Energy Direct Current Thermal Ablation System
Applicant	Galvanize Therapeutics, Inc. 1531 Industrial Road San Carlos, CA 94070 US Other 510(k) Applications for this Company
Contact	Deborah Sheffield Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	OAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2021
Decision Date	06/17/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review