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FDA 510(k)

COMPLETE CONTROL System Gen2

K-Number: K191083 · 2019-05-24

ApplicantCoapt, LLC
Decision Date2019-05-24
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPLETE CONTROL System Gen2 is the device name listed in this FDA 510(k) record. The listed applicant is Coapt, LLC. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K191083. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLETE CONTROL System Gen2?

COMPLETE CONTROL System Gen2 is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Coapt, LLC. The 510(k) number is K191083.

When did COMPLETE CONTROL System Gen2 receive FDA 510(k) clearance?

COMPLETE CONTROL System Gen2 received FDA 510(k) clearance on 2019-05-24, under 510(k) number K191083.

Who is the listed applicant for COMPLETE CONTROL System Gen2?

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

What is the FDA product code for COMPLETE CONTROL System Gen2?

The FDA product code for COMPLETE CONTROL System Gen2 is GXY.

Other records listing Coapt, LLC 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.

K223738Alpha Control Liner System (ACLS)K223605ControlSeal Electrode (ELSB)K190416Dome ElectrodeK162891Complete Control System

Related Devices (Code: GXY)

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.

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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.

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