Cleared Traditional

LUTZ NEEDLE

K013892 · Ballard Medical Products · Anesthesiology
Jul 2002
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K013892 is an FDA 510(k) clearance for the LUTZ NEEDLE, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on July 11, 2002, 230 days after receiving the submission on November 23, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K013892 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2001
Decision Date July 11, 2002
Days to Decision 230 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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