K240334
- 510(k) number
- K240334
- Device name
- LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
- Applicant
- Lagis Enterprise Co., Ltd. TW
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-10-30
- Date received
- 2024-02-05
- 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: K240334.pdf
Official FDA record: K240334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.