510(k) K222643
- Device
- Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- Applicant
- Sirius Medical Systems B.V.
- 510(k) number
- K222643
- Product code
- PBY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-19
- Date received
- 2022-09-01
- Regulation
- 878.4300
- Classification name
- Temporary Tissue Marker
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bram Schermers
- Address
- High Tech Campus 41 Eindhoven NL 5656AE 5656AE
FDA Registration Numbers#
- 3036009309
- 3012644426
- 3020733550
- 9611296
- 3026851515
Source Documents#
Other 510(k) Records For Product Code PBY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2023-11-09 |
| K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2021-02-24 |
| 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 |
| K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017-01-13 |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016-03-02 |
| K120804 | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM | Cianna Medical | 2013-02-04 |
Legacy Summary#
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FDA Review#
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