FDA 510(k) Application Details - K232262

Device Classification Name	Sigmoidoscope, Rigid, Electrical   More FDA Info for this Device
510(K) Number	K232262
Device Name	Sigmoidoscope, Rigid, Electrical
Applicant	SurgEase Innovations Limited Pendle Innovation Centre, Brook Street Nelson Lancashire BB9 9PU GB Other 510(k) Applications for this Company
Contact	Roger Parker Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2023
Decision Date	11/30/2023
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