K260318
- 510(k) number
- K260318
- Device name
- 4K NIR/ICG Imaging System
- Applicant
- Zhejiang Healnoc Technology Co., Ltd. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-05-26
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260318.pdf
Official FDA record: K260318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.