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FDA 510(k)

EdgeFlow UH10

K-Number: K231677 · 2024-03-06

ApplicantEdgecare, Inc.
Decision Date2024-03-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EdgeFlow UH10 is a medical device manufactured by Edgecare, Inc.. It received FDA 510(k) clearance on 2024-03-06 under approval number K231677. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EdgeFlow UH10?

EdgeFlow UH10 is a medical device that received FDA 510(k) clearance on 2024-03-06. It is manufactured by Edgecare, Inc.. The 510(k) number is K231677.

When was EdgeFlow UH10 approved by the FDA?

EdgeFlow UH10 received FDA 510(k) clearance on 2024-03-06, under approval number K231677.

What company makes EdgeFlow UH10?

EdgeFlow UH10 is manufactured by Edgecare, Inc..

What is the FDA product code for EdgeFlow UH10?

The FDA product code for EdgeFlow UH10 is IYO.

Other Devices by Edgecare, Inc.

K252337EdgeFlow Gel Pad K252237EdgeFlow UW20

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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.

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