FDA Product Code
FDA Product Code PBY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4300
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2023-11-09 | Traditional | PDF ↗ |
| K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2022-10-19 | Special | PDF ↗ |
| K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2021-02-24 | Traditional | PDF ↗ |
| K163667 | RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) | Health Beacons, Inc. | 2017-04-28 | Traditional | PDF ↗ |
| K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017-01-13 | Special | PDF ↗ |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016-03-02 | Traditional | PDF ↗ |
| K120804 | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM | Cianna Medical | 2013-02-04 | Traditional | PDF ↗ |
Product code PBY · Class II · General, Plastic Surgery. Data: openFDA.