FDA 510(k)

Agnes

K-Number: K192728 · 2019-10-24

Decision Date2019-10-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Agnes is a medical device manufactured by Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-10-24 under approval number K192728. 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?

Agnes is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Agnes Medical Co., Ltd.. The 510(k) number is K192728.

When was Agnes approved by the FDA?

Agnes received FDA 510(k) clearance on 2019-10-24, under approval number K192728.

What company makes Agnes?

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

What is the FDA product code for Agnes?

The FDA product code for Agnes is GEI.

Other Devices by Agnes Medical Co., Ltd.

K203013AGNES K223805Agnes K230837PlazMagik K250217AGNES Ultra K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) K242469RFMagik Lite

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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.