FDA 510(k)

4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)

N.º K: K252858 · 2026-04-30

SolicitanteKms Medical Technology Co., Ltd.

Fecha de decisión2026-04-30

Código de productoGCJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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