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K Number
K062984
Device Name
MEDLINE HYPODERMIC NEEDLES
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2006-11-13

(45 days)

Product Code
FMI
Regulation Number
880.5570
Type
Abbreviated
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Medline Disposable Sterile Hypodermic Needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for Medline Hypodermic Needles. It does not contain any information about acceptance criteria, study details, or device performance data.

The document discusses:

  • The FDA's determination of substantial equivalence to a legally marketed predicate device.
  • Regulatory classifications and requirements.
  • Indications for use of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text. The necessary information is not present in this document.

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).