FDA 510(k)

感應-輸尿管鏡 9 FR WL 600 MM（短RIWO D-URS），控制器用适配器 5525

K 號：K201897 · 2021-01-15

申請人Richard Wolf Medical Instruments Corporation

決定日期2021-01-15

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201897. 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 Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525?

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K201897.

When did Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 receive FDA 510(k) clearance?

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201897.

Who is the listed applicant for Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525?

The FDA product code for Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 is FGB.

其他以 Richard Wolf Medical Instruments Corporation 為申請人之記錄

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。

K231291穿孔籃 K230194HF外科電刀 400KHZ K212808Logic Hd 相機頭綠色，系統綠色 K211332D 相機控制器 K203226望遠鏡 0 O 10MM WL 305MM / 望遠鏡 30 O 10MM WL 305MM / 望遠鏡 50 O 10MM WL 305MM，望遠鏡 0 O 10MM WL 440MM / 望遠鏡 30 O 10MM WL 440MM / 望遠鏡 50 O 10MM WL 440MM K200617Logic HD 相機控制器，Logic HD Lite 相機控制器，Logic 4K 相機控制器，5525 控制器適配器

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相關器械（代碼：FGB）

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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