MICRORUPTOR 6
K-Number: K160677 · 2017-05-19
ApplicantMeridian AG
Decision Date2017-05-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MICRORUPTOR 6 is a medical device manufactured by Meridian AG. It received FDA 510(k) clearance on 2017-05-19 under approval number K160677. 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 MICRORUPTOR 6?
MICRORUPTOR 6 is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Meridian AG. The 510(k) number is K160677.
When was MICRORUPTOR 6 approved by the FDA?
MICRORUPTOR 6 received FDA 510(k) clearance on 2017-05-19, under approval number K160677.
What company makes MICRORUPTOR 6?
MICRORUPTOR 6 is manufactured by Meridian AG.
What is the FDA product code for MICRORUPTOR 6?
The FDA product code for MICRORUPTOR 6 is GEX. This falls under the Gastroenterology category.
Other Devices by Meridian AG
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.