FDA 510(k)

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

Numéro K : K161232 · 2016-09-30

Date de décision2016-09-30

Code produitBSO

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Halyard Health. The 510(k) number is K161232.

When did ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit?

The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : BSO)

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Source officielle

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