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FDA 510(k)

Monopolar Cord

K-Number: K193004 · 2019-12-19

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2019-12-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monopolar Cord is a medical device manufactured by New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K193004. 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 Monopolar Cord?

Monopolar Cord is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by New Deantronics Taiwan , Ltd.. The 510(k) number is K193004.

When was Monopolar Cord approved by the FDA?

Monopolar Cord received FDA 510(k) clearance on 2019-12-19, under approval number K193004.

What company makes Monopolar Cord?

Monopolar Cord is manufactured by New Deantronics Taiwan , Ltd..

What is the FDA product code for Monopolar Cord?

The FDA product code for Monopolar Cord 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 K191064Argon Handset 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

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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.

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