FDA 510(k) Application Details - K221907

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K221907
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Aerin Medical Inc. 2565 Leghorn St. Mountain View, CA 91043 US Other 510(k) Applications for this Company
Contact	Shannon Scott Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2022
Decision Date	07/29/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review