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 a medical device manufactured by Ellipse A/S. It received FDA 510(k) clearance on 2018-03-15 under approval 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. It is manufactured by Ellipse A/S. The 510(k) number is K180406.
When was Ellipse Ydun approved by the FDA?
Ellipse Ydun received FDA 510(k) clearance on 2018-03-15, under approval number K180406.
What company makes Ellipse Ydun?
Ellipse Ydun is manufactured by Ellipse A/S.
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 Devices by Ellipse A/S
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.