LogoFDA 510(k) Search
K Number
K000722

Validate with FDA (Live)

Device Name
UNIPOLAR NEEDLES
Manufacturer
PAJUNK GMBH
Date Cleared
2000-03-31

(28 days)

Product Code
BSP
Regulation Number
868.5150
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K013041,K033018,K033477,K042979,K043130,K063380,K100992,K173110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).