UniPearls® Embolic Microspheres— 510(k) K231554

Name: FDA 510(k) clearance K231554
Creator: U.S. Food and Drug Administration
Published: 2023-11-14

Substantially Equivalent

Suzhou Haowei Medical Technology Co., Ltd.

FDA 510(k) clearance K231554 for UniPearls® Embolic Microspheres, Substantially Equivalent on 2023-11-14. Applicant: Suzhou Haowei Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Haowei Medical Technology Co., Ltd.
Product code: Code KRD
Device class: Class 2
Regulation: 21 CFR 870.3300
Advisory panel: Cardiovascular
Date received: 2023-05-30
Decision date: 2023-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRD

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K252812 — UniPearls® Embolic Microspheres2026-07-31
K261488 — OBSIDIO Conformable Embolic2026-07-24
K261866 — Concerto Versa Detachable Coil2026-06-24
K260635 — HARBOR Occlusion Device2026-06-12
K260508 — LOBO Vascular Occlusion System2026-04-10

Adverse 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, 2020-01-01 through 2026-04-23. 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.