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FDA 510(k)

Standard Clamp

K-Number: K153358 · 2016-05-02

ApplicantStandard Bariatrics
Decision Date2016-05-02
Product CodeGDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Standard Clamp is a medical device manufactured by Standard Bariatrics. It received FDA 510(k) clearance on 2016-05-02 under approval number K153358. The device is classified under product code GDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Standard Clamp?

Standard Clamp is a medical device that received FDA 510(k) clearance on 2016-05-02. It is manufactured by Standard Bariatrics. The 510(k) number is K153358.

When was Standard Clamp approved by the FDA?

Standard Clamp received FDA 510(k) clearance on 2016-05-02, under approval number K153358.

What company makes Standard Clamp?

Standard Clamp is manufactured by Standard Bariatrics.

What is the FDA product code for Standard Clamp?

The FDA product code for Standard Clamp is GDJ.

Related Clinical Trials

NCT07568431 Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery NOT_YET_RECRUITING

Other Devices by Standard Bariatrics

K161720Standard Clamp K170379Disposable Standard Clamp K181608Disposable Standard Clamp K190788Disposable Standard Clamp K200517Standard Trocar K191885Standard Bougie

View all 10 devices →

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.

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