Stellar Medical 1055SM
Stellar Medical 1055SM is a Class II device made by Stellar Medical, LLC, cleared under FDA 510(k) K092041 on 2 Oct 2009 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 00853162006225), 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 | Number00853162006225 | Date17 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092041 | Date2 Oct 2009 | StatusActive |
Official records
- AccessGUDID record 00853162006225
- FDA 510(k) database K092041
Across registries
- FDA 510(k) K092041 decided 2 Oct 2009 Active
- FDA GUDID UDI-DI 00853162006225 listed 17 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K092041
- Listed FDA GUDID 00853162006225
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stellar Medical
- Generic name
- Radiological image marker, implantable
- Model / reference
- 1055SM
- Primary DI / UDI-DI
- 00853162006225
- 510(k) Number
- FDA product code
- KXK
- GMDN term
- Radiological image marker, implantable
- Device class
- Class II
- Regulation number
- 892.5730
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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