FDA 510(k)

AGNES Ultra

K-Number: K250217 · 2025-09-03

Decision Date2025-09-03

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AGNES Ultra is a medical device manufactured by Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-09-03 under approval number K250217. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGNES Ultra?

AGNES Ultra is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by Agnes Medical Co., Ltd.. The 510(k) number is K250217.

When was AGNES Ultra approved by the FDA?

AGNES Ultra received FDA 510(k) clearance on 2025-09-03, under approval number K250217.

What company makes AGNES Ultra?

AGNES Ultra is manufactured by Agnes Medical Co., Ltd..

What is the FDA product code for AGNES Ultra?

The FDA product code for AGNES Ultra is GEI.

Other Devices by Agnes Medical Co., Ltd.

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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.