PBY
7 FDA 510(k) clearances · Product code
135 daysmedian time to decision
341 days90th percentile
7clearances measured
FDA profile
- Official device name
- Temporary Tissue Marker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Medical specialty
- General, Plastic Surgery
- FDA definition
- To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K223682) | Sirius Medical Systems B.V. | 2023-11-09 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K222643) | Sirius Medical Systems B.V. | 2022-10-19 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K200734) | Sirius Medical Systems B.V. | 2021-02-24 |
| 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) (K163667) | Health Beacons, Inc. | 2017-04-28 |
| Magseed Magnetic Marker System (K163541) | Endomagnetics Ltd., | 2017-01-13 |
| Sentimag System, Sentimark Magnetic Marker Systerm (K153044) | Endomagnetics Ltd., | 2016-03-02 |
| CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM (K120804) | Cianna Medical | 2013-02-04 |
Track PBY automatically
Every clearance here is in the API, with alerts when new ones post.