Olive Plus
K-Number: K161981 · 2016-10-14
ApplicantAma Network, Inc.
Decision Date2016-10-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Olive Plus is a medical device manufactured by Ama Network, Inc.. It received FDA 510(k) clearance on 2016-10-14 under approval number K161981. 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 Olive Plus?
Olive Plus is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Ama Network, Inc.. The 510(k) number is K161981.
When was Olive Plus approved by the FDA?
Olive Plus received FDA 510(k) clearance on 2016-10-14, under approval number K161981.
What company makes Olive Plus?
Olive Plus is manufactured by Ama Network, Inc..
What is the FDA product code for Olive Plus?
The FDA product code for Olive Plus 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.