FDA 510(k) Application Details - K243750

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K243750
Device Name	Endoscopic Tissue Approximation Device
Applicant	Envision Endoscopy 204 Second Ave, 2nd Floor Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Azadeh Khanicheh Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2024
Decision Date	04/17/2025
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