Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by VIOL Co., Ltd.. It received FDA 510(k) clearance on 2024-11-26 under approval 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. It is manufactured by VIOL Co., Ltd.. The 510(k) number is K240897.

When was Cellinew approved by the FDA?

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

What company makes Cellinew?

Cellinew is manufactured by VIOL Co., Ltd..

What is the FDA product code for Cellinew?

The FDA product code for Cellinew is GEI.

Other Devices by VIOL Co., Ltd.

K172023CELFIRM K180872SCARLET SRF K200185SYLFIRM X K213612SYLFIRM X

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑