PICOHI
K-Number: K201773 · 2021-10-19
ApplicantHironic Co., Ltd.
Decision Date2021-10-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PICOHI is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2021-10-19 under approval number K201773. 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 PICOHI?
PICOHI is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K201773.
When was PICOHI approved by the FDA?
PICOHI received FDA 510(k) clearance on 2021-10-19, under approval number K201773.
What company makes PICOHI?
PICOHI is manufactured by Hironic Co., Ltd..
What is the FDA product code for PICOHI?
The FDA product code for PICOHI 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.