FDA 510(k)

EdgeFlow UW20

K-Number: K252237 · 2026-04-17

Decision Date2026-04-17

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EdgeFlow UW20 is the device name listed in this FDA 510(k) record. The listed applicant is Edgecare, Inc.. It received FDA 510(k) clearance on 2026-04-17 under 510(k) 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. The listed applicant is Edgecare, Inc.. The 510(k) number is K252237.

When did EdgeFlow UW20 receive FDA 510(k) clearance?

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

Who is the listed applicant for EdgeFlow UW20?

The FDA 510(k) record lists Edgecare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EdgeFlow UW20?

The FDA product code for EdgeFlow UW20 is IYO.

Other records listing Edgecare, Inc. as applicant

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.

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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.