SANDRO Dual
K-Number: K200110 · 2020-03-16
ApplicantWontech Co., Ltd.
Decision Date2020-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SANDRO Dual is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2020-03-16 under approval number K200110. 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 SANDRO Dual?
SANDRO Dual is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K200110.
When was SANDRO Dual approved by the FDA?
SANDRO Dual received FDA 510(k) clearance on 2020-03-16, under approval number K200110.
What company makes SANDRO Dual?
SANDRO Dual is manufactured by Wontech Co., Ltd..
What is the FDA product code for SANDRO Dual?
The FDA product code for SANDRO Dual is GEX. This falls under the Gastroenterology category.
Other Devices by Wontech Co., Ltd.
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.