K240196
- 510(k) number
- K240196
- Device name
- Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
- Applicant
- Yuwonmeditech Co., Ltd. KR
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-06-18
- Date received
- 2024-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240196.pdf
Official FDA record: K240196
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.