K231725
- 510(k) number
- K231725
- Device name
- Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
- Applicant
- Hunan Endoso Life Technology Co., Ltd. CN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2023-10-16
- Date received
- 2023-06-13
- 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: K231725.pdf
Official FDA record: K231725
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.