510(k) K210978
K210978 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2021
- Date Received
- April 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type