FDA 510(k) Application Details - K241039

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K241039
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	ReShape Lifesciences 18 Technology Drive Suite 110 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Eva Chang 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	04/16/2024
Decision Date	05/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review