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 |