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FDA 510(k)

Cellinew

K-Number: K240897 · 2024-11-26

ApplicantVIOL Co., Ltd.
Decision Date2024-11-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cellinew is the device name listed in this FDA 510(k) record. The listed applicant is VIOL Co., Ltd.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K240897. 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 Cellinew?

Cellinew is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is VIOL Co., Ltd.. The 510(k) number is K240897.

When did Cellinew receive FDA 510(k) clearance?

Cellinew received FDA 510(k) clearance on 2024-11-26, under 510(k) number K240897.

Who is the listed applicant for Cellinew?

The FDA 510(k) record lists VIOL Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cellinew?

The FDA product code for Cellinew is GEI.

Other records listing VIOL Co., Ltd. as applicant

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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.

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