Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
FDA 510(k) clearance K222643 · decided 2022-10-19
Clearance details
- K-number
- K222643
- Device name
- Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- Applicant
- Sirius Medical Systems B.V.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-01
- Decision date
- 2022-10-19
- Days to decision
- 48 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Sirius Medical Systems B.V.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K223682) | Sirius Medical Systems B.V. | 2023-11-09 |
| 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.