Juicebox J100
Juicebox J100 is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K111704 on 9 Sep 2011 and listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004073), 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 | Number00851354004073 | Date21 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111704 | Date9 Sep 2011 | StatusActive |
Official records
- AccessGUDID record 00851354004073
- FDA 510(k) database K111704
Across registries
- FDA 510(k) K111704 decided 9 Sep 2011 Active
- FDA GUDID UDI-DI 00851354004073 listed 21 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K111704
- Listed FDA GUDID 00851354004073
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Juicebox
- Generic name
- Torque manipulation device
- Model / Ref / Catalog
- J100
- Primary DI / UDI-DI
- 00851354004073
- 510(k) Number
- FDA product code
- DQY
- GMDN term
- Torque manipulation device
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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