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)

Disc-FX System

K-Number: K162490 · 2017-01-06

ApplicantElliquence, LLC
Decision Date2017-01-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disc-FX System is a medical device manufactured by Elliquence, LLC. It received FDA 510(k) clearance on 2017-01-06 under approval number K162490. 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 Disc-FX System?

Disc-FX System is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Elliquence, LLC. The 510(k) number is K162490.

When was Disc-FX System approved by the FDA?

Disc-FX System received FDA 510(k) clearance on 2017-01-06, under approval number K162490.

What company makes Disc-FX System?

Disc-FX System is manufactured by Elliquence, LLC.

What is the FDA product code for Disc-FX System?

The FDA product code for Disc-FX System is GEI.

Other Devices by Elliquence, LLC

K160041Cobbra RF Tissue Dissector K170107Surgi Max Ultra K180766Endiscope, Endiscope Cervical K243739AxCess® Expandable Interbody System

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.

↑