FDA 510(k) Application Details - K172796

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K172796
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	MEDROBOTICS CORPORATION 475 Paramount Drive Raynham, MA 02767 US Other 510(k) Applications for this Company
Contact	Linda J Varroso Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2017
Decision Date	01/18/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review