Picocare Family
K-Number: K181272 · 2018-07-31
ApplicantWontech Co., Ltd.
Decision Date2018-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Picocare Family is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2018-07-31 under approval number K181272. 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 Picocare Family?
Picocare Family is a medical device that received FDA 510(k) clearance on 2018-07-31. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K181272.
When was Picocare Family approved by the FDA?
Picocare Family received FDA 510(k) clearance on 2018-07-31, under approval number K181272.
What company makes Picocare Family?
Picocare Family is manufactured by Wontech Co., Ltd..
What is the FDA product code for Picocare Family?
The FDA product code for Picocare Family is GEX. This falls under the Gastroenterology category.
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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.