K250551

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

510(k) number: K250551
Device name: 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
Applicant: Shenzhen Sophway Technology Co., Ltd. CN
Product code: GCJ — Laparoscope, General & Plastic Surgery
Decision date: 2025-10-02
Date received: 2025-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

Also available from FDA: K250551.pdf

Official FDA record: K250551

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.