A-FIT
K-Number: K173676 · 2018-09-14
Device Summary
Frequently Asked Questions
What is the A-FIT?
A-FIT is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K173676.
When did A-FIT receive FDA 510(k) clearance?
A-FIT received FDA 510(k) clearance on 2018-09-14, under 510(k) number K173676.
Who is the listed applicant for A-FIT?
The FDA 510(k) record lists Hironic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for A-FIT?
The FDA product code for A-FIT is GEX. This falls under the Gastroenterology category.
Other records listing Hironic Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GEX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.