FDA 510(k) Application Details - K161086

Device Classification Name	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed   More FDA Info for this Device
510(K) Number	K161086
Device Name	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant	Sterilmed, Inc. 5010 Cheshire Parkway, Suite 2 Plymouth, MN 55446 US Other 510(k) Applications for this Company
Contact	Patricia Kaufman Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2016
Decision Date	09/20/2016
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