FDA 510(k) Application Details - K232701

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K232701
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Advanced Surgical Concepts Unit 4, Sunnybank Center Upper Dargle Road Bray A98 E339 IE Other 510(k) Applications for this Company
Contact	Edward Hyland 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	09/05/2023
Decision Date	09/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review