FDA 510(k)

AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches

Numéro K : K180848 · 2018-05-01

Date de décision2018-05-01

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

AMBIENT Super MULTIVAC 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 2018-05-01 under 510(k) number K180848. 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 Super MULTIVAC 50 Wand with Integrated Finger Switches?

AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is ArthroCare Corporation. The 510(k) number is K180848.

When did AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches receive FDA 510(k) clearance?

AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches received FDA 510(k) clearance on 2018-05-01, under 510(k) number K180848.

Who is the listed applicant for AMBIENT Super MULTIVAC 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 Super MULTIVAC 50 Wand with Integrated Finger Switches?

The FDA product code for AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches is GEI.

Essais cliniques associés

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Source officielle

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