Neurology · 510(k) · 2019
COMPLETE CONTROL System Gen2
Coapt, LLC. Cleared by FDA on 24 May 2019 under submission K191083, product code GXY (electrode, cutaneous). What FDA's record says, in FDA's words.
Device record · K191083
- Device. COMPLETE CONTROL System Gen2DEVICE
- Company. Coapt, LLCCOMPANY
- Decision. 24 May 2019, 510(k), substantially equivalent (special review); received 24 April 2019DECISION
- Panel. NeurologyPANEL
- Product code. GXY, Electrode, CutaneousCODE
- Regulation. 21 CFR 882.1320, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, principles of operation, technological characteristics, materials used, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or efficacy based on the similarities to the predicate device. Manufacturer: Coapt, LLC Coapt, LLC Device Comparison Trade Name: COMPLETE CONTROL System Gen2 COMPLETE CONTROL System 510(k) Number K191083 K162891 Not applicable Classification Product Code GXY GXY Same Regulation Number 21 CFR 882.1320 21 CFR 882.1320 Same Regulation Name Cutaneous electrode Cutaneous electrode Same Subsequent Product Code IQZ (Hand, External Limb Component, Powered) IQZ (Hand, External Limb Component, Powered) Same Indications for Use The COMPLETE CONTROL System Gen2 is to be used exclusively The COMPLETE CONTROL System is to be used exclusively for Same Coapt, LLC Special 510(k) Premarket Submission COMPLETE CONTROL System Gen2 Manufacturer: Coapt, LLC Coapt, LLC Device Comparison Trade Name: COMPLETE CONTROL System Gen2 COMPLETE CONTROL System for exoprosthetic fittings of the upper limbs. exoprosthetic fittings of the upper limbs. Use/Field of Application The COMPLETE CONTROL System Gen2 is suitable for unilateral or bilateral amputations. The COMPLETE CONTROL System is suitable for unilateral or bilateral amputations. Same Conditions of Use The COMPLETE CONTROL System Gen2 was developed for […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 534 reports filed against devices carrying product code GXY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
4 September 2026 · Malfunction · BIS · COVIDIEN · report 2936999-2026-00374
3 September 2026 · Injury · Biomet SpinalPak / OrthoPak · EBI, LLC. · report 0002242816-2026-00098
It was reported that the patient experienced skin irritation with the 63B electrodes. The patient discussed the issue with their doctor and advised that their doctor is in the process of prescribing a different device. No further information was provided.
2 September 2026 · Malfunction · BIS · COVIDIEN · report 2936999-2026-00368
2 September 2026 · Malfunction · BIS · COVIDIEN · report 2936999-2026-00370
25 August 2026 · Injury · Biomet SpinalPak / OrthoPak · EBI, LLC. · report 0002242816-2026-00096
It was reported that the electrodes irritated the patient¿s skin. The patient stated that their doctor would like them to use a different unit. No further information was provided.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code GXY, in Neurology, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.