A-FIT
K-Number: K173676 · 2018-09-14
ApplicantHironic Co., Ltd.
Decision Date2018-09-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
A-FIT is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2018-09-14 under approval number K173676. 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 A-FIT?
A-FIT is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K173676.
When was A-FIT approved by the FDA?
A-FIT received FDA 510(k) clearance on 2018-09-14, under approval number K173676.
What company makes A-FIT?
A-FIT is manufactured by Hironic Co., Ltd..
What is the FDA product code for A-FIT?
The FDA product code for A-FIT 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.