decimal Bolus (FlexiBol)
decimal Bolus (FlexiBol) is a Class II device made by .Decimal, LLC, cleared under FDA 510(k) K211511 on 1 Jul 2021 and listed in FDA GUDID since 1 Dec 2022 (UDI-DI 00851147007137), active as of 1 Jun 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 | Number00851147007137 | Date1 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211511 | Date1 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00851147007137
- FDA 510(k) database K211511
Across registries
- FDA 510(k) K211511 decided 1 Jul 2021 Active
- FDA GUDID UDI-DI 00851147007137 listed 1 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K211511
- Listed FDA GUDID 00851147007137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiation therapy beam block material
- Primary DI / UDI-DI
- 00851147007137
- 510(k) Number
- FDA product code
- MUJ, IXI
- GMDN term
- Radiation therapy beam block material
- Device class
- Class II
- Regulation number
- 892.5050, 892.5710
- GUDID distribution status
- In Commercial Distribution
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