uWS-Angio
K-Number: K250040 · 2025-09-12
Decision Date2025-09-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uWS-Angio is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-09-12 under approval number K250040. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uWS-Angio?
uWS-Angio is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K250040.
When was uWS-Angio approved by the FDA?
uWS-Angio received FDA 510(k) clearance on 2025-09-12, under approval number K250040.
What company makes uWS-Angio?
uWS-Angio is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uWS-Angio?
The FDA product code for uWS-Angio is LLZ.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: LLZ)
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.