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)

Argon Handset

K-Number: K191064 · 2019-06-12

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2019-06-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Argon Handset is a medical device manufactured by New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2019-06-12 under approval number K191064. 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 Argon Handset?

Argon Handset is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by New Deantronics Taiwan , Ltd.. The 510(k) number is K191064.

When was Argon Handset approved by the FDA?

Argon Handset received FDA 510(k) clearance on 2019-06-12, under approval number K191064.

What company makes Argon Handset?

Argon Handset is manufactured by New Deantronics Taiwan , Ltd..

What is the FDA product code for Argon Handset?

The FDA product code for Argon Handset is GEI.

Other Devices by New Deantronics Taiwan , Ltd.

K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated K170161New Deantronics E Green™ Electrosurgical Monopolar Pencils K180908Irrigation Tubing Bipolar Cord Set K193004Monopolar Cord K183126Electrosurgical accessory K183594Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J

View all 11 devices →

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.

↑