510(k) K945965

ATRAUMATIC PENCIL POINT SPINAL NEEDLE by Avid N.I.T., Inc. — Product Code BSP

K945965 is an FDA 510(k) premarket notification submitted by Avid N.I.T., Inc. for the device "ATRAUMATIC PENCIL POINT SPINAL NEEDLE". The FDA issued a decision of Substantially Equivalent on August 2, 1995. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Avid N.I.T., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1995
Date Received
December 7, 1994
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