510(k) K932569

PENCIL POINT SPINAL NEEDLE AND TRAY by B. Braun of America, Inc. — Product Code BSP

K932569 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "PENCIL POINT SPINAL NEEDLE AND TRAY". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
May 27, 1993
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