Fraxis
K-Number: K172096 · 2017-08-09
Device Summary
Frequently Asked Questions
What is the Fraxis?
Fraxis is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K172096.
When did Fraxis receive FDA 510(k) clearance?
Fraxis received FDA 510(k) clearance on 2017-08-09, under 510(k) number K172096.
Who is the listed applicant for Fraxis?
The FDA 510(k) record lists Ilooda Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fraxis?
The FDA product code for Fraxis is GEX. This falls under the Gastroenterology category.
Other records listing Ilooda 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.