FDA 510(k) Application Details - K162053

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K162053
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Invuity Inc. 444 De Haro Street San Francisco, CA 94107 US Other 510(k) Applications for this Company
Contact	John Kang 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	07/25/2016
Decision Date	09/15/2016
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