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K Number
K964230
Device Name
CORELIFE
Manufacturer
CORE HEALTHCARE LTD.
Date Cleared
1997-07-24

(274 days)

Product Code
FMF
Regulation Number
880.5860
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is used to inject fluids into or withdraw fluids from the body.

Device Description

CORELIFE (PISTON SYRINGE)

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device named "CORELIFE (PISTON SYRINGE)". It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document is a clearance letter and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot provide the requested information from the given text. The document is solely an FDA regulatory approval and does not delve into the technical details of device validation studies.

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).