HandPICO
K-Number: K220041 · 2022-05-05
Decision Date2022-05-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HandPICO is a medical device manufactured by Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2022-05-05 under approval number K220041. 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 HandPICO?
HandPICO is a medical device that received FDA 510(k) clearance on 2022-05-05. It is manufactured by Vydence Medical Industria E Comercio Ltda. The 510(k) number is K220041.
When was HandPICO approved by the FDA?
HandPICO received FDA 510(k) clearance on 2022-05-05, under approval number K220041.
What company makes HandPICO?
HandPICO is manufactured by Vydence Medical Industria E Comercio Ltda.
What is the FDA product code for HandPICO?
The FDA product code for HandPICO 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.