← Back to catalogue
Dewin Reproductive Media - Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
FDA 510(k)Class II (US FDA 510(k))
510(k) K251637
Identifiers
- 510(k) Number
- K251637 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
- Models / Variants
- Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dewin Reproductive Media - Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) by DonneVie Medical Technology(Shanghai)Co.Ltd…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251637 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DonneVie Medical Technology(Shanghai)Co.Ltd
- FDA Applicant
- Donnevie Medical Technology (Shanghai) Co. , Ltd.
Sources (1)
- FDA 510(k) K251637 24 fields · synced Jun 18, 2026