FDA 510(k)

一回使用型ビデオ尿路内視鏡（SVU-220US）

K番号: K241639 · 2024-07-01

決定日2024-07-01

製品コードFGB

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Single-use Video Ureterorenoscope (SVU-220US) is the device name listed in this FDA 510(k) record. The listed applicant is Huger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K241639. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Single-use Video Ureterorenoscope (SVU-220US)?

Single-use Video Ureterorenoscope (SVU-220US) is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Huger Medical Instrument Co., Ltd.. The 510(k) number is K241639.

When did Single-use Video Ureterorenoscope (SVU-220US) receive FDA 510(k) clearance?

Single-use Video Ureterorenoscope (SVU-220US) received FDA 510(k) clearance on 2024-07-01, under 510(k) number K241639.

Who is the listed applicant for Single-use Video Ureterorenoscope (SVU-220US)?

The FDA 510(k) record lists Huger Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Video Ureterorenoscope (SVU-220US)?

The FDA product code for Single-use Video Ureterorenoscope (SVU-220US) is FGB.

申請者としてHuger Medical Instrument Co., Ltd.を記載するその他の記録

K230475医療用ビデオ内視鏡システム

公式ソース

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