Cleared Traditional

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

K190026 · Teleflex Medical · Anesthesiology
Aug 2019
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K190026 is an FDA 510(k) clearance for the Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit), a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 21, 2019, 226 days after receiving the submission on January 7, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K190026 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2019
Decision Date August 21, 2019
Days to Decision 226 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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