Calibration Block
Part of a family of 6 devices: see the family page
Ref SYN-0014Model SYN-0642
Calibration Block (SYN-0014) is a device classified as Class I in the EU and Class II in the US made by Synaptive Medical Inc, registered in EUDAMED on 11 Apr 2025 (Basic UDI-DI 67008200005LR), cleared under FDA 510(k) K183325 on 14 Jul 2019 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00670082000023), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No date given
FDA recalls
None ongoingTrust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number67008200005LR 00670082000023 | Date11 Apr 2025 | StatusActive |
| United States | FDA 510(k)SESE GUDID | NumberK183325 | Date14 Jul 2019 | StatusActive |
| United States | GUDID listing GUDID | Number00670082000023 | Date24 Sep 2016 | StatusListed |
Official records
- EUDAMED public site 67008200005LR
- AccessGUDID record 00670082000023
- FDA 510(k) database K183325
- FDA 510(k) database K153281
Across registries
- EUDAMED Basic UDI-DI 67008200005LR registered 11 Apr 2025 Active
- FDA 510(k) K183325 decided 14 Jul 2019 Active
- FDA GUDID UDI-DI 00670082000023 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0470-2019
This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
Timeline
- Cleared FDA 510(k) K153281
- Listed FDA GUDID 00670082000023
- Recall initiated FDA recalls Z-0470-2019
- Cleared FDA 510(k) K183325
- Registered EUDAMED 67008200005LR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Calibration Block EUDAMEDBrightMatter Guide Calibration Block GUDID
- Generic name
- Neurological stereotactic surgery system
- Device name
- Standard Pointer
- Model / reference
- SYN-0642, SYN-0014
- Primary DI / UDI-DI
- 00670082000023
- Basic UDI-DI
- 67008200005LR
- Direct marketing DI
- 00670082000023
- FDA product code
- HAW
- EMDN code
- L031199 Probes and mirrors, reusable - other
- GMDN term
- Neurological stereotactic surgery system
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 882.4560
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CA-MF-000010705
- Authorised representative
- MDSS GmbH DE-AR-000005430
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