FDA 510(k) Application Details - K233240

Device Classification Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)   More FDA Info for this Device
510(K) Number	K233240
Device Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant	G-Surg GmbH Weinbergstrasse 28 Seeon-Seebruck 83370 DE Other 510(k) Applications for this Company
Contact	Julian Mair Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	06/21/2024
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