Picocaremajesty
K-Number: K212127 · 2022-01-07
ApplicantWontech Co., Ltd.
Decision Date2022-01-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Picocaremajesty is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2022-01-07 under approval number K212127. 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 Picocaremajesty?
Picocaremajesty is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K212127.
When was Picocaremajesty approved by the FDA?
Picocaremajesty received FDA 510(k) clearance on 2022-01-07, under approval number K212127.
What company makes Picocaremajesty?
Picocaremajesty is manufactured by Wontech Co., Ltd..
What is the FDA product code for Picocaremajesty?
The FDA product code for Picocaremajesty 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.