FDA 510(k)

CELFIRM

K-Number: K172023 · 2017-10-13

Decision Date2017-10-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CELFIRM is a medical device manufactured by VIOL Co., Ltd.. It received FDA 510(k) clearance on 2017-10-13 under approval number K172023. 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 CELFIRM?

CELFIRM is a medical device that received FDA 510(k) clearance on 2017-10-13. It is manufactured by VIOL Co., Ltd.. The 510(k) number is K172023.

When was CELFIRM approved by the FDA?

CELFIRM received FDA 510(k) clearance on 2017-10-13, under approval number K172023.

What company makes CELFIRM?

CELFIRM is manufactured by VIOL Co., Ltd..

What is the FDA product code for CELFIRM?

The FDA product code for CELFIRM is GEI.

Other Devices by VIOL Co., Ltd.

K180872SCARLET SRF K200185SYLFIRM X K213612SYLFIRM X K240897Cellinew

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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.