510(k) K233813
K233813 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Bearing nsPVA Express". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2023
- Date Received
- November 30, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agents, Embolic, For Treatment Of Uterine Fibroids
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- OB
- Submission Type