Cleared Traditional

RX EPIDURAL NEEDLE

K053318 · Epimed International, Inc. · Anesthesiology
Feb 2006
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K053318 is an FDA 510(k) clearance for the RX EPIDURAL NEEDLE, 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 February 17, 2006, 79 days after receiving the submission on November 30, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K053318 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2005
Decision Date February 17, 2006
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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