Standard Bougie
K-Number: K191885 · 2020-04-08
ApplicantStandard Bariatrics
Decision Date2020-04-08
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Standard Bougie is a medical device manufactured by Standard Bariatrics. It received FDA 510(k) clearance on 2020-04-08 under approval number K191885. 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 Standard Bougie?
Standard Bougie is a medical device that received FDA 510(k) clearance on 2020-04-08. It is manufactured by Standard Bariatrics. The 510(k) number is K191885.
When was Standard Bougie approved by the FDA?
Standard Bougie received FDA 510(k) clearance on 2020-04-08, under approval number K191885.
What company makes Standard Bougie?
Standard Bougie is manufactured by Standard Bariatrics.
What is the FDA product code for Standard Bougie?
The FDA product code for Standard Bougie is KNT.
Other Devices by Standard Bariatrics
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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.