FDA 510(k) Application Details - K221642

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K221642
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	Precision Robotics (Hong Kong) Limited Suite 611-612 Lakeside 2, 10W, Hong Kong Science Park,New Territories Hong Kong 0000 CN Other 510(k) Applications for this Company
Contact	Ping Lai Benny Lo 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	06/06/2022
Decision Date	12/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review