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FDA 510(k)

4K UHD內視鏡攝影系統 (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)

K 號：K252858 · 2026-04-30

申請人Kms Medical Technology Co., Ltd.
決定日期2026-04-30
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) is the device name listed in this FDA 510(k) record. The listed applicant is Kms Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K252858. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)?

4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Kms Medical Technology Co., Ltd.. The 510(k) number is K252858.

When did 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) receive FDA 510(k) clearance?

4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) received FDA 510(k) clearance on 2026-04-30, under 510(k) number K252858.

Who is the listed applicant for 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)?

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

What is the FDA product code for 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)?

The FDA product code for 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) is GCJ.

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：GCJ）

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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