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FDA 510(k)

Symphion Operative Hysteroscopy System

Número K: K233710 · 2024-01-17

RequerenteMinerva Surgical, Inc.
Data da decisão2024-01-17
Código do produtoPGT
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Symphion Operative Hysteroscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Minerva Surgical, Inc.. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233710. The device is classified under product code PGT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Symphion Operative Hysteroscopy System?

Symphion Operative Hysteroscopy System is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Minerva Surgical, Inc.. The 510(k) number is K233710.

When did Symphion Operative Hysteroscopy System receive FDA 510(k) clearance?

Symphion Operative Hysteroscopy System received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233710.

Who is the listed applicant for Symphion Operative Hysteroscopy System?

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

What is the FDA product code for Symphion Operative Hysteroscopy System?

The FDA product code for Symphion Operative Hysteroscopy System is PGT.

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Fonte oficial

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