FDA 510(k) Application Details - K222880

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K222880
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Endolumik Inc. 364 Patteson Dr. #293 Morgantown, WV 26505 US Other 510(k) Applications for this Company
Contact	Mara McFadden Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2022
Decision Date	03/03/2023
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