FDA 510(k)

Standard Clamp

K-Number: K153358 · 2016-05-02

Decision Date2016-05-02

Product CodeGDJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Standard Clamp is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2016-05-02 under 510(k) 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. The listed applicant is Standard Bariatrics. The 510(k) number is K153358.

When did Standard Clamp receive FDA 510(k) clearance?

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

Who is the listed applicant for Standard Clamp?

The FDA 510(k) record lists Standard Bariatrics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Clamp?

The FDA product code for Standard Clamp is GDJ.

Other records listing Standard Bariatrics as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.