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)

Ellusa Bipolar Wands

K-Number: K202558 · 2020-11-02

ApplicantEllusa, LLC
Decision Date2020-11-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ellusa Bipolar Wands is a medical device manufactured by Ellusa, LLC. It received FDA 510(k) clearance on 2020-11-02 under approval number K202558. 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 Ellusa Bipolar Wands?

Ellusa Bipolar Wands is a medical device that received FDA 510(k) clearance on 2020-11-02. It is manufactured by Ellusa, LLC. The 510(k) number is K202558.

When was Ellusa Bipolar Wands approved by the FDA?

Ellusa Bipolar Wands received FDA 510(k) clearance on 2020-11-02, under approval number K202558.

What company makes Ellusa Bipolar Wands?

Ellusa Bipolar Wands is manufactured by Ellusa, LLC.

What is the FDA product code for Ellusa Bipolar Wands?

The FDA product code for Ellusa Bipolar Wands is GEI.

Other Devices by Ellusa, LLC

K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set K222429Ellusa Reusable Bipolar Cable K222425Ellusa Reusable Neutral Plates

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.

↑