UniPearls® Embolic Microspheres— 510(k) K252812
Substantially EquivalentSuzhou Haowei Medical Technology Co., Ltd.
FDA 510(k) clearance K252812 for UniPearls® Embolic Microspheres, Substantially Equivalent on 2026-07-31. Applicant: Suzhou Haowei Medical Technology Co., Ltd.. Device class: 2.
Summary
UniPearls Embolic Microspheres from Suzhou Haowei Medical Technology are filed under KRD, vascular devices for promoting embolization. The record doesn't give sizes or materials.
Class II, 21 CFR 870.3300. The Gastroenterology and Urology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Suzhou Haowei filed from Suzhou, China. Review took 330 calendar days (September 4, 2025 to July 31, 2026).
Clearance details
- Applicant
- Suzhou Haowei Medical Technology Co., Ltd.
- Product code
- Product code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code KRD
view allMore clearances from Suzhou Haowei Medical Technology Co., Ltd.
view allAdverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.