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FDA 510(k)

Alpha Control Liner System (ACLS)

K-Number: K223738 · 2023-01-11

ApplicantCoapt
Decision Date2023-01-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Alpha Control Liner System (ACLS) is the device name listed in this FDA 510(k) record. The listed applicant is Coapt. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K223738. 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 Alpha Control Liner System (ACLS)?

Alpha Control Liner System (ACLS) is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Coapt. The 510(k) number is K223738.

When did Alpha Control Liner System (ACLS) receive FDA 510(k) clearance?

Alpha Control Liner System (ACLS) received FDA 510(k) clearance on 2023-01-11, under 510(k) number K223738.

Who is the listed applicant for Alpha Control Liner System (ACLS)?

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

What is the FDA product code for Alpha Control Liner System (ACLS)?

The FDA product code for Alpha Control Liner System (ACLS) is GXY.

Other records listing Coapt 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.

K223605ControlSeal Electrode (ELSB)K191083COMPLETE CONTROL System Gen2K190416Dome 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.

K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed EuropeK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.

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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