FDA 510(k)

單次使用數位柔軟輸尿管鏡(F-URS)（ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04）

K 號：K243155 · 2025-02-11

申請人Dongguan Zsr Biomedical Technology Company Limited

決定日期2025-02-11

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) 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 2025-02-11 under 510(k) number K243155. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)?

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K243155.

When did Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) receive FDA 510(k) clearance?

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243155.

Who is the listed applicant for Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)?

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 Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)?

The FDA product code for Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) is FGB.

其他以 Dongguan Zsr Biomedical Technology Company Limited 為申請人之記錄

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K241181一次性輸尿管導引鞘

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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