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FDA 510(k)

柔軟輸尿管鏡（U-Scope）（2.8/1.2）(OMI161-2F28-CH12-US)；柔軟輸尿管鏡（U-Scope）（2.5/1.2）(OMI161-2F25-CH12-US)；圖像系統（攝影機控制單元）(OMI01M12)

K 號：K242699 · 2025-05-28

申請人Opcom Medical, Inc.
決定日期2025-05-28
產品代碼FGB
諮詢委員會GU
決定相當於

器材摘要

Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) is the device name listed in this FDA 510(k) record. The listed applicant is Opcom Medical, Inc.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K242699. 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 Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)?

Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Opcom Medical, Inc.. The 510(k) number is K242699.

When did Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) receive FDA 510(k) clearance?

Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) received FDA 510(k) clearance on 2025-05-28, under 510(k) number K242699.

Who is the listed applicant for Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)?

The FDA 510(k) record lists Opcom Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)?

The FDA product code for Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) is FGB.

相關臨床試驗

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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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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官方來源

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