Cleared Traditional

PENCIL POINT NEEDLE

K041843 · Epimed International, Inc. · Anesthesiology
Aug 2004
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K041843 is an FDA 510(k) clearance for the PENCIL POINT 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 August 24, 2004, 47 days after receiving the submission on July 8, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K041843 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2004
Decision Date August 24, 2004
Days to Decision 47 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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