510(k) K242561
K242561 is an FDA 510(k) premarket notification submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. for the device "Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Donnevie Medical Technology (Shanghai) Co. , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2025
- Date Received
- August 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type