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Ellipse Ydun

Ellipse A/S

Country / Region:Denmark (DK)Submission type:Special

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

Ellipse A/S logoEllipse A/S
Denmark (DK)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K180406
Device name
Ellipse Ydun
Company
Ellipse A/S
Country / Region
Denmark(DK)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-02-14
Decision date
2018-03-15
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Intended Use

(K161162) listed on page 1 of this document.
The Ellipse Ydun system has been evaluated and compared to the above mentioned predicate system and
applications, parameters, and intended use/indications for use, and have been judged to be substantially
equivalent to the mentioned

Device Description

, performance, intended use/indications for use, to the

Summary parsed at:2026-06-01 05:57:08 UTC

Predicate devices

1
  • K161162

    Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

    Ellipse A/S

K180406 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K180406 as a predicate