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K Number
K011122
Device Name
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
Manufacturer
RUSCH INTL.
Date Cleared
2001-11-16

(218 days)

Product Code
BSP
Regulation Number
868.5150
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).