FDA 510(k)

Bipolar applicator CELON ProCurve V

Numéro K : K172535 · 2017-11-16

Date de décision2017-11-16

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Bipolar applicator CELON ProCurve V 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 2017-11-16 under 510(k) number K172535. 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 Bipolar applicator CELON ProCurve V?

Bipolar applicator CELON ProCurve V is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K172535.

When did Bipolar applicator CELON ProCurve V receive FDA 510(k) clearance?

Bipolar applicator CELON ProCurve V received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172535.

Who is the listed applicant for Bipolar applicator CELON ProCurve V?

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 Bipolar applicator CELON ProCurve V?

The FDA product code for Bipolar applicator CELON ProCurve V is GEI.

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Source officielle

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