4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
K-Number: K252858 · 2026-04-30
ApplicantKms Medical Technology Co., Ltd.
Decision Date2026-04-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) is a medical device manufactured by Kms Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-30 under approval number K252858. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Kms Medical Technology Co., Ltd.. The 510(k) number is K252858.
When was 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) approved by the FDA?
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) received FDA 510(k) clearance on 2026-04-30, under approval number K252858.
What company makes 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 manufactured by Kms Medical Technology Co., Ltd..
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.
Related Devices (Code: GCJ)
Official Source
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