K232262
- 510(k) number
- K232262
- Device name
- LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
- Applicant
- Surgease Innovations Limited GB
- Product code
- FAN — Sigmoidoscope, Rigid, Electrical
- Decision date
- 2023-11-30
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232262.pdf
Official FDA record: K232262
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.