SkyWalker NB-10147
by Microport Navibot International LLC
SkyWalker NB-10147 is a Class II device made by Microport Navibot International LLC, cleared under FDA 510(k) K213873 on 7 Jul 2022 and listed in FDA GUDID since 29 Jun 2023 (UDI-DI 00850030914323), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850030914323 | Date29 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213873 | Date7 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 00850030914323
- FDA 510(k) database K213873
Across registries
- FDA 510(k) K213873 decided 7 Jul 2022 Active
- FDA GUDID UDI-DI 00850030914323 listed 29 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K213873
- Listed FDA GUDID 00850030914323
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SkyWalker
- Generic name
- Imaging lesion localization marker, external, single-use
- Model / Ref / Catalog
- NB-10147
- Primary DI / UDI-DI
- 00850030914323
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Imaging lesion localization marker, external, single-use
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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