FDA 510(k) Application Details - K230133

Device Classification Name	More FDA Info for this Device
510(K) Number	K230133
Device Name	Plenity
Applicant	Gelesis Inc. 501 Boyston St., Ste. 6102 Boston, MA 02116 US Other 510(k) Applications for this Company
Contact	Yverre Bobay Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2023
Decision Date	01/19/2024
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