Atlas FDA

BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle

FDA 510(k) clearance K193131 · decided 2020-09-29

Clearance details

K-number
K193131
Device name
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2019-11-12
Decision date
2020-09-29
Days to decision
322 days
Clearance type
Traditional
Product code
BSP
Device class
2
Regulation number
868.5150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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