510(k) K252812
K252812 is an FDA 510(k) premarket notification submitted by Suzhou Haowei Medical Technology Co., Ltd. for the device "UniPearls® Embolic Microspheres". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Suzhou Haowei Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2026
- Date Received
- September 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vascular, For Promoting Embolization
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- CV
- Submission Type