FDA 510(k) Application Details - K250268

Device Classification Name	More FDA Info for this Device
510(K) Number	K250268
Device Name	HyperSnap Surgical System (HSS)
Applicant	Hypervision Surgical London Institute for Healthcare Engineering 100 Lambeth Palace Road London SE1 7AR GB Other 510(k) Applications for this Company
Contact	Jaco Jacobs Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SFE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2025
Decision Date	06/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review