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FDA 510(k)

Complete Control System

K-Number: K162891 · 2017-04-14

ApplicantCoapt, LLC
Decision Date2017-04-14
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Complete Control System is a medical device manufactured by Coapt, LLC. It received FDA 510(k) clearance on 2017-04-14 under approval number K162891. 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?

Complete Control System is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Coapt, LLC. The 510(k) number is K162891.

When was Complete Control System approved by the FDA?

Complete Control System received FDA 510(k) clearance on 2017-04-14, under approval number K162891.

What company makes Complete Control System?

Complete Control System is manufactured by Coapt, LLC.

What is the FDA product code for Complete Control System?

The FDA product code for Complete Control System 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)

Other Devices by Coapt, LLC

K191083COMPLETE CONTROL System Gen2 K190416Dome Electrode

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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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