PBY
- Product code
- PBY
- Device name
- Temporary Tissue Marker
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
FDA classification definition
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K223682 | 2023-11-09 | Sirius Medical Systems B.V. | Sirius Pintuition Seed, Sirius Pintuition Probe, Sir |
Official FDA classification page: PBY
Classification and pathway per current FDA publications. Data from openFDA (CC0).