FDA 510(k) Application Details - K241796

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K241796
Device Name	Laparoscope, General & Plastic Surgery
Applicant	TroCare, LLC 1000 Louisiana Street Fifty Third Floor Houston, TX 77002 US Other 510(k) Applications for this Company
Contact	Kenneth Kleinhenz Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2024
Decision Date	10/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review