SpiraBrush CX SBX-9000
SpiraBrush CX SBX-9000 is a Class I device made by Histologics, LLC, cleared under FDA 510(k) K011488 on 22 Feb 2002 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 00860275000309), active as of 8 Nov 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 | Number00860275000309 | Date28 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011488 | Date22 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 00860275000309
- FDA 510(k) database K011488
Across registries
- FDA 510(k) K011488 decided 22 Feb 2002 Active
- FDA GUDID UDI-DI 00860275000309 listed 28 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K011488
- Listed FDA GUDID 00860275000309
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SpiraBrush CX
- Generic name
- Cervical cytology scraper, single-use
- Model / Ref / Catalog
- SBX-9000
- Primary DI / UDI-DI
- 00860275000309
- 510(k) Number
- FDA product code
- HFB
- GMDN term
- Cervical cytology scraper, single-use
- Device class
- Class I
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
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