Thoraguard FGS-1125
Thoraguard FGS-1125 (TGDK110012) is a Class II device made by Centese, Inc., cleared under FDA 510(k) K181667 on 29 Nov 2018 and listed in FDA GUDID since 7 Oct 2020 (UDI-DI 00860000436410), 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 | Number00860000436410 | Date7 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181667 | Date29 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 00860000436410
- FDA 510(k) database K181667
Across registries
- FDA 510(k) K181667 decided 29 Nov 2018 Active
- FDA GUDID UDI-DI 00860000436410 listed 7 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K181667
- Listed FDA GUDID 00860000436410
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thoraguard
- Generic name
- Surgical suction system collection container, single-use
- Model / Ref / Catalog
- FGS-1125, TGDK110012
- Primary DI / UDI-DI
- 00860000436410
- 510(k) Number
- FDA product code
- BTA
- GMDN term
- Surgical suction system collection container, single-use
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
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