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FDA 510(k)

SYLFIRM X

K-Number: K213612 · 2022-06-23

ApplicantVIOL Co., Ltd.
Decision Date2022-06-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYLFIRM X is a medical device manufactured by VIOL Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under approval number K213612. 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 SYLFIRM X?

SYLFIRM X is a medical device that received FDA 510(k) clearance on 2022-06-23. It is manufactured by VIOL Co., Ltd.. The 510(k) number is K213612.

When was SYLFIRM X approved by the FDA?

SYLFIRM X received FDA 510(k) clearance on 2022-06-23, under approval number K213612.

What company makes SYLFIRM X?

SYLFIRM X is manufactured by VIOL Co., Ltd..

What is the FDA product code for SYLFIRM X?

The FDA product code for SYLFIRM X is GEI.

Other Devices by VIOL Co., Ltd.

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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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