FDA 510(k)

FertiCult フラッシングミディアム；フェノールレッドとゲンタマイシンを含むFertiCult フラッシングミディアム

K番号: K242640 · 2025-05-30

決定日2025-05-30

製品コードMQL

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin is the device name listed in this FDA 510(k) record. The listed applicant is Fertipro NV. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K242640. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin?

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Fertipro NV. The 510(k) number is K242640.

When did FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin receive FDA 510(k) clearance?

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242640.

Who is the listed applicant for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin?

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

What is the FDA product code for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin?

The FDA product code for FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin is MQL.

申請者としてFertipro NVを記載するその他の記録

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