FDA 510(k)

Ambient HipVac 50 Wand avec Interrupteurs à Doigt Intégrés

Numéro K : K161481 · 2016-10-21

Date de décision2016-10-21

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Ambient HipVac 50 Wand with Integrated Finger Switches is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K161481. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Ambient HipVac 50 Wand with Integrated Finger Switches?

Ambient HipVac 50 Wand with Integrated Finger Switches is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is ArthroCare Corporation. The 510(k) number is K161481.

When did Ambient HipVac 50 Wand with Integrated Finger Switches receive FDA 510(k) clearance?

Ambient HipVac 50 Wand with Integrated Finger Switches received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161481.

Who is the listed applicant for Ambient HipVac 50 Wand with Integrated Finger Switches?

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

What is the FDA product code for Ambient HipVac 50 Wand with Integrated Finger Switches?

The FDA product code for Ambient HipVac 50 Wand with Integrated Finger Switches is GEI.

Essais cliniques associés

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Autres dossiers indiquant ArthroCare Corporation en tant que demandeur

K254122FLOW FLEXTEND Wand (72290039)K253680LYNX COBLATION Laryngeal Wand (72290254)K240964FLOW 90? Wand K232290INTELLIO SHIFT System K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)K220563Ambient HipVac 50 Wand avec Interrupteurs à Doigt Intégrés, Système de COBLATION RF20000, Système de COBLATION WEREWOLF, Système de COBLATION WEREWOLF+

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Source officielle

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