Cleared Traditional

TUOHY EPIDURAL NEEDLE

K030562 · Epimed International, Inc. · Anesthesiology
Apr 2003
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K030562 is an FDA 510(k) clearance for the TUOHY 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 April 3, 2003, 41 days after receiving the submission on February 21, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K030562 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2003
Decision Date April 03, 2003
Days to Decision 41 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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