510(k) K211085

BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle by Becton, Dickinson and Company — Product Code BSP

K211085 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle". The FDA issued a decision of Substantially Equivalent on July 1, 2022. 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
July 1, 2022
Date Received
April 12, 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