K223682
- 510(k) number
- K223682
- Device name
- Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- Applicant
- Sirius Medical Systems B.V. NL
- Product code
- PBY — Temporary Tissue Marker
- Decision date
- 2023-11-09
- Date received
- 2022-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K223682.pdf
Official FDA record: K223682
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.