FDA 510(k)

EdgeFlow UH10

K-Number: K231677 · 2024-03-06

Decision Date2024-03-06

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EdgeFlow UH10 is the device name listed in this FDA 510(k) record. The listed applicant is Edgecare, Inc.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) 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. The listed applicant is Edgecare, Inc.. The 510(k) number is K231677.

When did EdgeFlow UH10 receive FDA 510(k) clearance?

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

Who is the listed applicant for EdgeFlow UH10?

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 UH10?

The FDA product code for EdgeFlow UH10 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.