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FDA 510(k)

Ellipse Ydun

K-Number: K180406 · 2018-03-15

ApplicantEllipse A/S
Decision Date2018-03-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ellipse Ydun is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse A/S. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K180406. 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 Ydun?

Ellipse Ydun is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Ellipse A/S. The 510(k) number is K180406.

When did Ellipse Ydun receive FDA 510(k) clearance?

Ellipse Ydun received FDA 510(k) clearance on 2018-03-15, under 510(k) number K180406.

Who is the listed applicant for Ellipse Ydun?

The FDA 510(k) record lists Ellipse A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ellipse Ydun?

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

Other records listing Ellipse A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunK161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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