Sentimag System
FDA 510(k) clearance K222832 · decided 2023-01-21
Clearance details
- K-number
- K222832
- Device name
- Sentimag System
- Applicant
- Endomagnetics Ltd.,
- Decision
- Substantially Equivalent
- Date received
- 2022-09-20
- Decision date
- 2023-01-21
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- NEU
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cambridge, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Magtrace® and Sentimag® Magnetic Locatization System (PUV) (P160053/S011) | Endomagnetics Ltd., | 2024-07-03 |
| Magtrace and Sentimag Magnetic Locatization System (PUV) (P160053/S010) | Endomagnetics Ltd., | 2024-06-07 |
| Magtrace and Sentimag Magnetic Localization System (P160053/S009) | Endomagnetics Ltd., | 2024-04-15 |
| Magtrace® and Sentimag® Magnetic Locatization System (PUV) (P160053/S007) | Endomagnetics Ltd., | 2023-06-29 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S002) | Endomagnetics Ltd., | 2022-12-06 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S005) | Endomagnetics Ltd., | 2022-09-13 |
| Magtrace/and Sentimag Magnetic Localization System (P160053/S004) | Endomagnetics Ltd., | 2021-09-20 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S001) | Endomagnetics Ltd., | 2019-05-08 |