V-Onestep
510(k) K193285
V-Onestep is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by VITROMED GmbH, cleared under FDA 510(k) K193285 on 20 Nov 2020, active as of 11 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 | NumberK193285 | Date20 Nov 2020 | StatusActive |
Official records
- FDA 510(k) database K193285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193285
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 | |||
|---|---|---|---|---|
| V-ONESTEP V-OSM-10 | V-OSM-10 / V-OSM-10 | 04260650070013 | — | On the market |
| V-ONESTEP V-OSM-20 | V-OSM-20 / V-OSM-20 | 04260650071614 | — | On the market |
| V-ONESTEP V-OSM-20P | V-OSM-20P / V-OSM-20P | 04260650070020 | — | On the market |
| V-ONESTEP V-OSM-60 | V-OSM-60 / V-OSM-60 | 04260650072437 | — | On the market |
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