V-Sperm Wash
510(k) K223117
V-Sperm Wash is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by VITROMED GmbH, cleared under FDA 510(k) K223117 on 31 Jan 2023, active as of 12 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 | NumberK223117 | Date31 Jan 2023 | StatusActive |
Official records
- FDA 510(k) database K223117
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- Withdrawn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 K223117
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-SPERM WASH V-SWM-100 | V-SWM-100 | 04260650070105 | — | On the market |
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Other devices filed under FDA product code MQL (Media, Reproductive).
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- Gx-IVF 10171 by Vitrolife Sweden AB