K250820
- 510(k) number
- K250820
- Device name
- Disposable Trocars
- Applicant
- Sinolinks Medical Innovation, Inc. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2025-07-11
- Date received
- 2025-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250820.pdf
Official FDA record: K250820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.