Sepa Sperm 60%
by Kitazato Corporation 2 variants
Sepa Sperm 60% (92040) is a Class II device made by Kitazato Corporation, cleared under FDA 510(k) K190199 on 26 Sep 2019 and listed in FDA GUDID since 13 Jan 2023 (UDI-DI 04573316381287), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04573316381287 | Date13 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190199 | Date26 Sep 2019 | StatusActive |
Official records
- AccessGUDID record 04573316381287
- FDA 510(k) database K190199
Across registries
- FDA 510(k) K190199 decided 26 Sep 2019 Active
- FDA GUDID UDI-DI 04573316381287 listed 13 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K190199
- Listed FDA GUDID 04573316381287
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- IVF medium
- Model / Ref / Catalog
- Sepa Sperm 60%, 92040
- Primary DI / UDI-DI
- 04573316381287
- 510(k) Number
- FDA product code
- MQL
- GMDN term
- IVF medium
- Device class
- Class II
- Regulation number
- 884.6180
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under IVF medium.
- Quinn's Advantage Fertilization (HTF) Medium ART-1021 by CooperSurgical, Inc.
- OVOIL HEAVY 10174 by Vitrolife Sweden AB
- PureCeption 40% Upper Phase ART-2040 by CooperSurgical, Inc.
- Gx-TL 10172 by Vitrolife Sweden AB
- Oil for Embryo Culture 9305-500ML by IRVINE SCIENTIFIC, LLC
- V-OIL-500G by VITROMED GmbH
- Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin 90128-20X5mL by FUJIFILM IRVINE SCIENTIFIC, INC.