LogoFDA 510(k) Search
K Number
K033166
Device Name
KACEY INSULIN SYRINGE
Manufacturer
KACEY, INC.
Date Cleared
2003-12-12

(73 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 product is intended for use by individuals who have been directed by and are under the supervision of professional staff to use insulin injections as a means to control the effects of diabetes.

The product is intended to be used in any setting that meets the needs of the user.

Device Description

Piston Syringe

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a Kacey Insulin Syringe. This document does not contain information about the acceptance criteria and the study that proves the device meets those criteria. It is a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide a response to your request based on the provided text.

§ 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).