Picowon
K-Number: K201406 · 2020-07-22
ApplicantWontech Co., Ltd.
Decision Date2020-07-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Picowon is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2020-07-22 under approval number K201406. 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 Picowon?
Picowon is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K201406.
When was Picowon approved by the FDA?
Picowon received FDA 510(k) clearance on 2020-07-22, under approval number K201406.
What company makes Picowon?
Picowon is manufactured by Wontech Co., Ltd..
What is the FDA product code for Picowon?
The FDA product code for Picowon 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.