Cleared Traditional

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit

K161232 · Halyard Health · Anesthesiology
Sep 2016
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K161232 is an FDA 510(k) clearance for the ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on September 30, 2016, 151 days after receiving the submission on May 2, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K161232 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2016
Decision Date September 30, 2016
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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