TheraSeed® TS200CSA
TheraSeed® TS200CSA is a Class II device made by Bard Brachytherapy, Inc, cleared under FDA 510(k) K060636 on 19 Apr 2006 and listed in FDA GUDID since 5 Oct 2015 (UDI-DI 00801741091353), active as of 23 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 | Number00801741091353 | Date5 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060636 | Date19 Apr 2006 | StatusActive |
Official records
- AccessGUDID record 00801741091353
- FDA 510(k) database K060636
Across registries
- FDA 510(k) K060636 decided 19 Apr 2006 Active
- FDA GUDID UDI-DI 00801741091353 listed 5 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K060636
- Listed FDA GUDID 00801741091353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TheraSeed®
- Generic name
- Manual brachytherapy source, permanent implant
- Model / Ref / Catalog
- TS200CSA
- Primary DI / UDI-DI
- 00801741091353
- 510(k) Number
- FDA product code
- KXK
- GMDN term
- Manual brachytherapy source, permanent implant
- Device class
- Class II
- Regulation number
- 892.5730
- GUDID distribution status
- In Commercial Distribution
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