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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Tissue Marker
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,  NL 5656AE
Applicant Contact Bram Schermers
Correspondent
Sirius Medical Systems B.V.
High Tech Campus 41
Eindhoven,  NL 5656AE
Correspondent Contact Bram Schermers
Regulation Number878.4300
Classification Product Code
PBY  
Date Received09/01/2022
Decision Date 10/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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