FDA 510(k)

Standard Clamp

K-Number: K161720 · 2016-10-24

Decision Date2016-10-24

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Standard Clamp is a medical device manufactured by Standard Bariatrics. It received FDA 510(k) clearance on 2016-10-24 under approval number K161720. 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 Standard Clamp?

Standard Clamp is a medical device that received FDA 510(k) clearance on 2016-10-24. It is manufactured by Standard Bariatrics. The 510(k) number is K161720.

When was Standard Clamp approved by the FDA?

Standard Clamp received FDA 510(k) clearance on 2016-10-24, under approval number K161720.

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 GCJ.

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

K153358Standard Clamp K170379Disposable Standard Clamp K181608Disposable Standard Clamp K190788Disposable Standard Clamp K200517Standard Trocar K191885Standard Bougie

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Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien K162059EZEE RETRIEVALGenicon, Inc.

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.