GastroFlush
K-Number: K180605 · 2018-10-24
ApplicantBionix Development Corporation
Decision Date2018-10-24
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
GastroFlush is a medical device manufactured by Bionix Development Corporation. It received FDA 510(k) clearance on 2018-10-24 under approval number K180605. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GastroFlush?
GastroFlush is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Bionix Development Corporation. The 510(k) number is K180605.
When was GastroFlush approved by the FDA?
GastroFlush received FDA 510(k) clearance on 2018-10-24, under approval number K180605.
What company makes GastroFlush?
GastroFlush is manufactured by Bionix Development Corporation.
What is the FDA product code for GastroFlush?
The FDA product code for GastroFlush is KNT.
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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.