Sunsphere
K-Number: K232934 · 2024-05-30
Decision Date2024-05-30
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sunsphere is a medical device manufactured by Hangzhou Yangshun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-05-30 under approval 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. It is manufactured by Hangzhou Yangshun Medical Technology Co.,Ltd. The 510(k) number is K232934.
When was Sunsphere approved by the FDA?
Sunsphere received FDA 510(k) clearance on 2024-05-30, under approval number K232934.
What company makes Sunsphere?
Sunsphere is manufactured by Hangzhou Yangshun Medical Technology Co.,Ltd.
What is the FDA product code for Sunsphere?
The FDA product code for Sunsphere is KRD.
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.