FDA 510(k)

Bovie Disposable Bipolar Ablator

Número K: K152777 · 2016-01-15

Data da decisão2016-01-15

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bovie Disposable Bipolar Ablator is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152777. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bovie Disposable Bipolar Ablator?

Bovie Disposable Bipolar Ablator is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Bovie Medical Corporation. The 510(k) number is K152777.

When did Bovie Disposable Bipolar Ablator receive FDA 510(k) clearance?

Bovie Disposable Bipolar Ablator received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152777.

Who is the listed applicant for Bovie Disposable Bipolar Ablator?

The FDA 510(k) record lists Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bovie Disposable Bipolar Ablator?

The FDA product code for Bovie Disposable Bipolar Ablator is GEI.

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Outros registros que listam Bovie Medical Corporation como candidato(a)

K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces K170777Bovie J-Plasma Precise FLEX Handpiece K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator

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Fonte oficial

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