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K Number
K012868
Device Name
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
Manufacturer
MICROMEDICS, INC.
Date Cleared
2001-10-29

(63 days)

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

The Micromedics FibriJet Aerosol Applicator is intended for use in applying two non-homogeneous fluids to a treatment site.

Device Description

Not Found

AI/ML Overview

This is a PMA (Premarket Approval) letter and does not contain the information requested. There are no acceptance criteria, device performance, or study details included in this document. This letter primarily focuses on the FDA's decision regarding the substantial equivalence of the Micromedics FibriJet Aerosol Applicator to legally marketed predicate devices and outlines regulatory compliance requirements.

§ 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).