FlexSys
K-Number: K203054 · 2021-03-05
ApplicantGme German Medical Engineering GmbH
Decision Date2021-03-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FlexSys is a medical device manufactured by Gme German Medical Engineering GmbH. It received FDA 510(k) clearance on 2021-03-05 under approval number K203054. 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 FlexSys?
FlexSys is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Gme German Medical Engineering GmbH. The 510(k) number is K203054.
When was FlexSys approved by the FDA?
FlexSys received FDA 510(k) clearance on 2021-03-05, under approval number K203054.
What company makes FlexSys?
FlexSys is manufactured by Gme German Medical Engineering GmbH.
What is the FDA product code for FlexSys?
The FDA product code for FlexSys is GEX. This falls under the Gastroenterology category.
Other Devices by Gme German Medical Engineering GmbH
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.