K243867
- 510(k) number
- K243867
- Device name
- LAGIS Suction Irrigation System
- Applicant
- Lagis Enterprise Co., Ltd. TW
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2025-03-17
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243867.pdf
Official FDA record: K243867
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.