FDA 510(k)

Sunsphere

K-Number: K232934 · 2024-05-30

ApplicantHangzhou Yangshun Medical Technology Co.,Ltd

Decision Date2024-05-30

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sunsphere is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Yangshun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-05-30 under 510(k) number K232934. 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 Sunsphere?

Sunsphere is a medical device that received FDA 510(k) clearance on 2024-05-30. The listed applicant is Hangzhou Yangshun Medical Technology Co.,Ltd. The 510(k) number is K232934.

When did Sunsphere receive FDA 510(k) clearance?

Sunsphere received FDA 510(k) clearance on 2024-05-30, under 510(k) number K232934.

Who is the listed applicant for Sunsphere?

The FDA 510(k) record lists Hangzhou Yangshun Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sunsphere?

The FDA product code for Sunsphere is KRD.

Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

Official Source

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