FDA 510(k)

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

Numéro K : K233425 · 2024-01-25

Date de décision2024-01-25

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2024-01-25 under 510(k) number K233425. 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 FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is a medical device that received FDA 510(k) clearance on 2024-01-25. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K233425.

When did FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) receive FDA 510(k) clearance?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) received FDA 510(k) clearance on 2024-01-25, under 510(k) number K233425.

Who is the listed applicant for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

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

What is the FDA product code for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

The FDA product code for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is GEI.

Essais cliniques associés

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Autres dossiers indiquant Sutter Medizintechnik GmbH en tant que demandeur

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Source officielle

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