BD Syringe NRFit Lok and BD Syringe NRFit Slip
FDA 510(k) K192538 · Becton, Dickinson and Company
Submission
- Device name
- BD Syringe NRFit Lok and BD Syringe NRFit Slip
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- September 16, 2019
- Decision date
- September 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEH – Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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…
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Questions and answers
When was BD Syringe NRFit Lok and BD Syringe NRFit Slip cleared by the FDA?
BD Syringe NRFit Lok and BD Syringe NRFit Slip (K192538) received a 510(k) decision of Substantially Equivalent on September 4, 2020, 354 days after the submission was received.
What is the product code of K192538?
The FDA product code is QEH – Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact , a Class II (moderate risk) device regulated under 21 CFR 880.5860.