FDA 510(k)

Resection Electrodes

Numéro K : K161600 · 2016-09-06

Date de décision2016-09-06

Code produitJOS

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Resection Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161600. The device is classified under product code JOS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Resection Electrodes?

Resection Electrodes is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K161600.

When did Resection Electrodes receive FDA 510(k) clearance?

Resection Electrodes received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161600.

Who is the listed applicant for Resection Electrodes?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resection Electrodes?

The FDA product code for Resection Electrodes is JOS.

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