Cleared Traditional

Entellus Medical Reinforced Anesthesia Needle

K163435 · Entellus Medical, Inc. · Anesthesiology
Apr 2017
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K163435 is an FDA 510(k) clearance for the Entellus Medical Reinforced Anesthesia Needle, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 5, 2017, 119 days after receiving the submission on December 7, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K163435 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2016
Decision Date April 05, 2017
Days to Decision 119 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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