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FDA 510(k)

Reusable Monopolar Active Cord

K-Number: K192518 · 2019-10-25

ApplicantUs Endoscopy
Decision Date2019-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reusable Monopolar Active Cord is a medical device manufactured by Us Endoscopy. It received FDA 510(k) clearance on 2019-10-25 under approval number K192518. 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 Reusable Monopolar Active Cord?

Reusable Monopolar Active Cord is a medical device that received FDA 510(k) clearance on 2019-10-25. It is manufactured by Us Endoscopy. The 510(k) number is K192518.

When was Reusable Monopolar Active Cord approved by the FDA?

Reusable Monopolar Active Cord received FDA 510(k) clearance on 2019-10-25, under approval number K192518.

What company makes Reusable Monopolar Active Cord?

Reusable Monopolar Active Cord is manufactured by Us Endoscopy.

What is the FDA product code for Reusable Monopolar Active Cord?

The FDA product code for Reusable Monopolar Active Cord is GEI.

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Official Source

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