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510(k) Data Aggregation
K Number
K251111Device Name
Cary
Manufacturer
Excitus AS
Date Cleared
2025-05-07
(26 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Excitus AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
Device Description
[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
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