Cleared Traditional

UltraCath Continuous Nerve block Catheter

K162522 · Teleflexmedical, Inc. · Anesthesiology
Mar 2017
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K162522 is an FDA 510(k) clearance for the UltraCath Continuous Nerve block Catheter, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on March 17, 2017, 189 days after receiving the submission on September 9, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K162522 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date March 17, 2017
Days to Decision 189 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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