Cleared Traditional

K043467 - FLEXIBLE SPINAL NEEDLE
(FDA 510(k) Clearance)

K043467 · Epimed International, Inc. · Anesthesiology

Mar 2005

Decision

106d

Days

Class 2

Risk

K043467 is an FDA 510(k) clearance for the FLEXIBLE SPINAL NEEDLE. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP).

Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on March 31, 2005, 106 days after receiving the submission on December 15, 2004.

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

Submission Details

510(k) Number	K043467 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2004
Decision Date	March 31, 2005
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF