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FDA 510(k)

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

K-Number: K192951 · 2020-03-26

ApplicantEllipse A/S
Decision Date2020-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is a medical device manufactured by Ellipse A/S. It received FDA 510(k) clearance on 2020-03-26 under approval number K192951. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun?

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Ellipse A/S. The 510(k) number is K192951.

When was Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun approved by the FDA?

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun received FDA 510(k) clearance on 2020-03-26, under approval number K192951.

What company makes Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun?

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is manufactured by Ellipse A/S.

What is the FDA product code for Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun?

The FDA product code for Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun is GEX. This falls under the Gastroenterology category.

Other Devices by Ellipse A/S

K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra K180406Ellipse Ydun

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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