Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
FDA 510(k) clearance K223682 · decided 2023-11-09
Clearance details
- K-number
- K223682
- Device name
- Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- Applicant
- Sirius Medical Systems B.V.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-08
- Decision date
- 2023-11-09
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- PBY
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Eindhoven, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.