510(k) K222643
K222643 is an FDA 510(k) premarket notification submitted by Sirius Medical Systems B.V. for the device "Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit". The FDA issued a decision of Substantially Equivalent on October 19, 2022. The device falls under product code PBY (Temporary Tissue Marker), a Class II device regulated under 21 CFR 878.4300. Sirius Medical Systems B.V. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2022
- Date Received
- September 1, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Tissue Marker
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.