4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)— 510(k) K252858
Substantially EquivalentKms Medical Technology Co., Ltd.
FDA 510(k) clearance K252858 for 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288), Substantially Equivalent on 2026-04-30. Applicant: Kms Medical Technology Co., Ltd.. Device class: 2.
Summary
Kms Medical Technology's 4K UHD Endoscopy Camera System is filed under product code GCJ (Laparoscope, General & Plastic Surgery). The name lists three model numbers: KMS-4K-2088, KMS-4K-2188, and KMS-4K-2288.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Kms Medical Technology filed from Changsha, China. The decision came 233 calendar days after FDA received it (September 9, 2025 to April 30, 2026).
Clearance details
- Applicant
- Kms Medical Technology Co., Ltd.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changsha, CN
Recent devices under product code GCJ
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.