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FDA 510(k)

EdgeFlow UW20

K-Number: K252237 · 2026-04-17

ApplicantEdgecare, Inc.
Decision Date2026-04-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EdgeFlow UW20 is a medical device manufactured by Edgecare, Inc.. It received FDA 510(k) clearance on 2026-04-17 under approval number K252237. 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 UW20?

EdgeFlow UW20 is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Edgecare, Inc.. The 510(k) number is K252237.

When was EdgeFlow UW20 approved by the FDA?

EdgeFlow UW20 received FDA 510(k) clearance on 2026-04-17, under approval number K252237.

What company makes EdgeFlow UW20?

EdgeFlow UW20 is manufactured by Edgecare, Inc..

What is the FDA product code for EdgeFlow UW20?

The FDA product code for EdgeFlow UW20 is IYO.

Other Devices by Edgecare, Inc.

K231677EdgeFlow UH10 K252337EdgeFlow Gel Pad

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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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