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)

DUET-V (Model: ESK-3261DV)

K-Number: K233118 · 2025-01-03

ApplicantEunsung Global Corp
Decision Date2025-01-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUET-V (Model: ESK-3261DV) is a medical device manufactured by Eunsung Global Corp. It received FDA 510(k) clearance on 2025-01-03 under approval number K233118. 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 DUET-V (Model: ESK-3261DV)?

DUET-V (Model: ESK-3261DV) is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Eunsung Global Corp. The 510(k) number is K233118.

When was DUET-V (Model: ESK-3261DV) approved by the FDA?

DUET-V (Model: ESK-3261DV) received FDA 510(k) clearance on 2025-01-03, under approval number K233118.

What company makes DUET-V (Model: ESK-3261DV)?

DUET-V (Model: ESK-3261DV) is manufactured by Eunsung Global Corp.

What is the FDA product code for DUET-V (Model: ESK-3261DV)?

The FDA product code for DUET-V (Model: ESK-3261DV) is GEI.

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.

↑