St-Z5
by Z-Systems AG
510(k) K201878
St-Z5 is a Class II device made by Z-Systems AG, cleared under FDA 510(k) K201878 on 25 Mar 2021, 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 | FDA 510(k)SESE | NumberK201878 | Date25 Mar 2021 | StatusActive |
Official records
- FDA 510(k) database K201878
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KCT
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201878
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Z5-BL_TL-leer | Z5-BL_TL-leer / Z5-BL_TL-leer | 07640166767893 | — | On the market |
| Z5_m_c_mt Inlay | Z5_m_c_mt Inlay / Z5_m_c_mt Inlay | 07640166761754 | — | On the market |
| Z5_m_c_mt leer | Z5_m_c_mt leer / Z5_m_c_mt leer | 07640166761747 | — | On the market |
| Z5_m_c_mt Tray FULL | Z5_m_c_mt Tray FULL / Z5_m_c_mt Tray FULL | 07640166761778 | — | On the market |
| Z5_Tray_Box | Z5_Tray_Box / Z5_Tray_Box | 07640166761761 | — | On the market |
| Z5m(t)-neo Insert | Z5m(t)-neo Insert / Z5m(t)-neo Insert | 07640166769521 | — | On the market |
| Z5m(t)-neo Tray Full | Z5m(t)-neo Tray Full / Z5m(t)-neo Tray Full | 07640166769651 | — | On the market |
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