FDA 510(k) Application Details - K241213

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K241213
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	Pentax of America, Inc 3 Paragon Dr Montvale, NJ 07645 US Other 510(k) Applications for this Company
Contact	Gurvinder Singh Nanda Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2024
Decision Date	12/06/2024
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