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FDA 510(k)

ELLIPSE MULTIFLEX

K-Number: K081408 · 2008-10-17

ApplicantEllipse A/S
Decision Date2008-10-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELLIPSE MULTIFLEX 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 2008-10-17 under 510(k) number K081408. 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 MULTIFLEX?

ELLIPSE MULTIFLEX is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Ellipse A/S. The 510(k) number is K081408.

When did ELLIPSE MULTIFLEX receive FDA 510(k) clearance?

ELLIPSE MULTIFLEX received FDA 510(k) clearance on 2008-10-17, under 510(k) number K081408.

Who is the listed applicant for ELLIPSE MULTIFLEX?

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 MULTIFLEX?

The FDA product code for ELLIPSE MULTIFLEX 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 UltraK072023ELLIPSE JUVIA, MODEL 9EJU7465

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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