Reusable guide
by Koelis
Ref GPK-490Model Reusable guide
Reusable guide (GPK-490) is a Class I device made by Koelis, registered in EUDAMED on 13 Oct 2022 (Basic UDI-DI 3665134GPK_01UR) and cleared under FDA 510(k) K141334 on 11 Jul 2014, active as of 25 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number3665134GPK_01UR 03665134000790 | Date13 Oct 2022 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK141334 | Date11 Jul 2014 | StatusActive |
Official records
- EUDAMED public site 3665134GPK_01UR
- FDA 510(k) database K141334
Across registries
- EUDAMED Basic UDI-DI 3665134GPK_01UR registered 13 Oct 2022 Active
- FDA 510(k) K141334 decided 11 Jul 2014 Active
Timeline
- Cleared FDA 510(k) K141334
- Registered EUDAMED 3665134GPK_01UR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Model / reference
- Reusable guide, GPK-490
- Primary DI / UDI-DI
- 03665134000790
- Basic UDI-DI
- 3665134GPK_01UR
- Direct marketing DI
- 03665134000790
- EMDN code
- Z11049080 Various ultrasound instruments - hardware accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000830
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