FDA 510(k) Application Details - K223256

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K223256
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	Taewoong Medical Co., Ltd. 14 Gojeong-Ro, Wolgot-Myeon Gimpo-Si 10022 KR Other 510(k) Applications for this Company
Contact	Yongjin Jeff Kim Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2022
Decision Date	04/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review