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FDA 510(k)

ELLIPSE JUVIA, MODEL 9EJU7465

K-Number: K072023 · 2007-09-12

ApplicantEllipse A/S
Decision Date2007-09-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELLIPSE JUVIA, MODEL 9EJU7465 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 2007-09-12 under 510(k) number K072023. 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 JUVIA, MODEL 9EJU7465?

ELLIPSE JUVIA, MODEL 9EJU7465 is a medical device that received FDA 510(k) clearance on 2007-09-12. The listed applicant is Ellipse A/S. The 510(k) number is K072023.

When did ELLIPSE JUVIA, MODEL 9EJU7465 receive FDA 510(k) clearance?

ELLIPSE JUVIA, MODEL 9EJU7465 received FDA 510(k) clearance on 2007-09-12, under 510(k) number K072023.

Who is the listed applicant for ELLIPSE JUVIA, MODEL 9EJU7465?

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 JUVIA, MODEL 9EJU7465?

The FDA product code for ELLIPSE JUVIA, MODEL 9EJU7465 is GEX. This falls under the Gastroenterology category.

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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 YdunK180406Ellipse YdunK161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraK081408ELLIPSE MULTIFLEX

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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