Disposable Standard Clamp
K-Number: K190788 · 2019-04-18
ApplicantStandard Bariatrics
Decision Date2019-04-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Disposable Standard Clamp is a medical device manufactured by Standard Bariatrics. It received FDA 510(k) clearance on 2019-04-18 under approval number K190788. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Standard Clamp?
Disposable Standard Clamp is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Standard Bariatrics. The 510(k) number is K190788.
When was Disposable Standard Clamp approved by the FDA?
Disposable Standard Clamp received FDA 510(k) clearance on 2019-04-18, under approval number K190788.
What company makes Disposable Standard Clamp?
Disposable Standard Clamp is manufactured by Standard Bariatrics.
What is the FDA product code for Disposable Standard Clamp?
The FDA product code for Disposable Standard Clamp is GCJ.
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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.