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FDA 510(k)

Standard Trocar

K-Number: K200517 · 2020-04-09

Decision Date2020-04-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Standard Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200517. 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 Trocar?

Standard Trocar is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Standard Bariatrics. The 510(k) number is K200517.

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

Standard Trocar received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200517.

Who is the listed applicant for Standard Trocar?

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 Trocar?

The FDA product code for Standard Trocar 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.