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U.S. Department of Health and Human Services

Product Classification

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Device piston syringe with neuraxial connector – epidural, peripheral, and/or indirect cerebral spinal fluid contact
Regulation Description Piston syringe.
Definition A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Physical State A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger.
Technical Method A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. The connector may be compliant with ANSI/AAMI/ISO 80369-6: 2016: “Small bore connectors for liquids and gases in healthcare applications – Part 6 Connectors for neuraxial applications”
Target Area Sites for the neuraxial application include the epidural, peripheral nerve, subarachnoid/spinal block, intrathecal and/or intracerebroventricular locations.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQEH
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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