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FDA 510(k)

Disposable Standard Clamp

K-Number: K190788 · 2019-04-18

Decision Date2019-04-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable 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 2019-04-18 under 510(k) 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. The listed applicant is Standard Bariatrics. The 510(k) number is K190788.

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

Disposable Standard Clamp received FDA 510(k) clearance on 2019-04-18, under 510(k) number K190788.

Who is the listed applicant for Disposable 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 Disposable Standard Clamp?

The FDA product code for Disposable Standard Clamp is GCJ.

Other records listing Standard Bariatrics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 12 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.