510(k) K241833
K241833 is an FDA 510(k) premarket notification submitted by Vitromed GmbH for the device "V-GRAD". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Vitromed GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2025
- Date Received
- June 25, 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