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FDA 510(k)

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

K-Number: K161232 · 2016-09-30

ApplicantHalyard Health
Decision Date2016-09-30
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is a medical device manufactured by Halyard Health. It received FDA 510(k) clearance on 2016-09-30 under approval number K161232. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit?

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Halyard Health. The 510(k) number is K161232.

When was ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit approved by the FDA?

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit received FDA 510(k) clearance on 2016-09-30, under approval number K161232.

What company makes ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit?

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is manufactured by Halyard Health.

What is the FDA product code for ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit?

The FDA product code for ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is BSO.

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Related Devices (Code: BSO)

K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. K152952E-CathPAJUNK GmbH Medizintechnologie K150731Medline Epidural CatheterMedline Industries, Inc. K150789SPINAUT-E, SPINAUT-IImedicom Co., Ltd. K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc. K171193Certa CatheterFerrosan Medical Devices Sp. Z.O.O.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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