FDA 510(k)

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Número K: K213171 · 2022-05-26

Data da decisão2022-05-26

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) is the device name listed in this FDA 510(k) record. The listed applicant is Meditrina, Inc.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K213171. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Meditrina, Inc.. The 510(k) number is K213171.

When did Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) receive FDA 510(k) clearance?

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) received FDA 510(k) clearance on 2022-05-26, under 510(k) number K213171.

Who is the listed applicant for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

The FDA 510(k) record lists Meditrina, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)?

The FDA product code for Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) is HIH.

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