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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 a medical device manufactured by Coapt, LLC. It received FDA 510(k) clearance on 2019-05-24 under approval 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. It is manufactured by Coapt, LLC. The 510(k) number is K191083.

When was COMPLETE CONTROL System Gen2 approved by the FDA?

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

What company makes COMPLETE CONTROL System Gen2?

COMPLETE CONTROL System Gen2 is manufactured by Coapt, LLC.

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

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

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Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

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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.

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