Cleared Traditional

K932569 - PENCIL POINT SPINAL NEEDLE AND TRAY
(FDA 510(k) Clearance)

K932569 · B. Braun of America, Inc. · Anesthesiology

Jan 1994

Decision

244d

Days

Class 2

Risk

K932569 is an FDA 510(k) clearance for the PENCIL POINT SPINAL NEEDLE AND TRAY. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP).

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 26, 1994, 244 days after receiving the submission on May 27, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number	K932569 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 1993
Decision Date	January 26, 1994
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement