The following data is part of a premarket notification filed by Sirius Medical Systems B.v. with the FDA for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit.
Device ID | K222643 |
510k Number | K222643 |
Device Name: | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
Classification | Temporary Tissue Marker |
Applicant | Sirius Medical Systems B.V. High Tech Campus 41 Eindhoven, NL 5656AE |
Contact | Bram Schermers |
Correspondent | Bram Schermers Sirius Medical Systems B.V. High Tech Campus 41 Eindhoven, NL 5656AE |
Product Code | PBY |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-09-01 |
Decision Date | 2022-10-19 |