FDA 510(k)

disposable 尿管導入鞘

K番号: K241181 · 2024-08-02

申請者Dongguan Zsr Biomedical Technology Company Limited

決定日2024-08-02

製品コードFED

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

Disposable Ureteral Guide Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241181. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Disposable Ureteral Guide Sheath?

Disposable Ureteral Guide Sheath is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K241181.

When did Disposable Ureteral Guide Sheath receive FDA 510(k) clearance?

Disposable Ureteral Guide Sheath received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241181.

Who is the listed applicant for Disposable Ureteral Guide Sheath?

The FDA 510(k) record lists Dongguan Zsr Biomedical Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Ureteral Guide Sheath?

The FDA product code for Disposable Ureteral Guide Sheath is FED.

申請者としてDongguan Zsr Biomedical Technology Company Limitedを記載するその他の記録

K243155単回使用型デジタル柔軟性尿管内視鏡（F-URS）（ZSR-URS-01、ZSR-URS-02、ZSR-URS-03、ZSR-URS-04）

公式ソース

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