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FDA 510(k)

EsCem RMGI

K-Number: K250566 · 2025-06-20

ApplicantSpident Co., Ltd.
Decision Date2025-06-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EsCem RMGI is a medical device manufactured by Spident Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval number K250566. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EsCem RMGI?

EsCem RMGI is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Spident Co., Ltd.. The 510(k) number is K250566.

When was EsCem RMGI approved by the FDA?

EsCem RMGI received FDA 510(k) clearance on 2025-06-20, under approval number K250566.

What company makes EsCem RMGI?

EsCem RMGI is manufactured by Spident Co., Ltd..

What is the FDA product code for EsCem RMGI?

The FDA product code for EsCem RMGI is EMA.

Other Devices by Spident Co., Ltd.

K161774i-Sil K214076EsCem K214071Hexa-Temp K231523EsCom250 K242702VioSeal K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)

View all 9 devices →

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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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