Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UniPearls® Embolic Microspheres

K-Number: K231554 · 2023-11-14

ApplicantSuzhou Haowei Medical Technology Co., Ltd.
Decision Date2023-11-14
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UniPearls® Embolic Microspheres is a medical device manufactured by Suzhou Haowei Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-14 under approval number K231554. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniPearls® Embolic Microspheres?

UniPearls® Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Suzhou Haowei Medical Technology Co., Ltd.. The 510(k) number is K231554.

When was UniPearls® Embolic Microspheres approved by the FDA?

UniPearls® Embolic Microspheres received FDA 510(k) clearance on 2023-11-14, under approval number K231554.

What company makes UniPearls® Embolic Microspheres?

UniPearls® Embolic Microspheres is manufactured by Suzhou Haowei Medical Technology Co., Ltd..

What is the FDA product code for UniPearls® Embolic Microspheres?

The FDA product code for UniPearls® Embolic Microspheres is KRD.

Related Clinical Trials

NCT05112926 Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40246727 [Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑