FDA 510(k) Application Details - K243867

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K243867
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Lagis Enterprise Co., Ltd. No. 29, Gong 1st Rd., Dajia Dist. Taichung City 43762 TW Other 510(k) Applications for this Company
Contact	Lynn Chen 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	12/17/2024
Decision Date	03/17/2025
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