FDA 510(k)

Unité de Coagulation au Plasma d'Argon APC 3, Unité Electrosurgicale VIO 3, Probes FiAPC, APC Hybride, Applicateurs APC, Réducteur de Pression APC avec Capteur, Chariot VIO, Jeu de Fixations

Numéro K : K191234 · 2019-12-20

Date de décision2019-12-20

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191234. 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 APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets?

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K191234.

When did APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets receive FDA 510(k) clearance?

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191234.

Who is the listed applicant for APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets?

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

What is the FDA product code for APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets?

The FDA product code for APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets is GEI.

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Source officielle

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