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K Number
K100665
Device Name
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
Manufacturer
NEEDLETECH PRODUCTS, INC.
Date Cleared
2010-06-24

(108 days)

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

The MARROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

Device Description

MARROWMAX Bone Marrow Aspiration Needle Kit

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a bone marrow aspiration needle kit. It confirms substantial equivalence to a predicate device but does not contain any information about acceptance criteria, performance data, or studies that prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval for marketing the device.

§ 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).