NeuGuide™ FG0001
NeuGuide™ FG0001 is a Class II device made by Femselect Ltd, cleared under FDA 510(k) K160569 on 6 Jul 2016 and listed in FDA GUDID since 20 Oct 2017 (UDI-DI 07290017082004), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290017082004 | Date20 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160569 | Date6 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 07290017082004
- FDA 510(k) database K160569
Across registries
- FDA 510(k) K160569 decided 6 Jul 2016 Active
- FDA GUDID UDI-DI 07290017082004 listed 20 Oct 2017 Listed
Recalls
-
- Ongoing Z-0556-2022
Certain lots may not have been packaged wth the Channel Tube Limiter.
Timeline
- Cleared FDA 510(k) K160569
- Listed FDA GUDID 07290017082004
- Recall initiated FDA recalls Z-0556-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeuGuide™
- Generic name
- Ligament graft, synthetic polymer
- Model / Ref / Catalog
- FG0001
- Primary DI / UDI-DI
- 07290017082004
- 510(k) Number
- FDA product code
- PBQ
- GMDN term
- Ligament graft, synthetic polymer
- Device class
- Class II
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).