K252697
- 510(k) number
- K252697
- Device name
- 3D Laparoscope
- Applicant
- Guangdong Optomedic Technologies, Inc. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2025-10-29
- Date received
- 2025-08-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252697.pdf
Official FDA record: K252697
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.