K252858
- 510(k) number
- K252858
- Device name
- 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
- Applicant
- Kms Medical Technology Co., Ltd. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-04-30
- Date received
- 2025-09-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252858.pdf
Official FDA record: K252858
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.