FDA 510(k) Application Details - K222643

Device Classification Name	More FDA Info for this Device
510(K) Number	K222643
Device Name	Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Applicant	Sirius Medical Systems B.V. High Tech Campus 41 Eindhoven 5656AE NL Other 510(k) Applications for this Company
Contact	Bram Schermers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2022
Decision Date	10/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review