LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )— 510(k) K232262
Substantially EquivalentSurgease Innovations Limited
FDA 510(k) clearance K232262 for LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ), Substantially Equivalent on 2023-11-30. Applicant: Surgease Innovations Limited.
Clearance details
- Applicant
- Surgease Innovations Limited
- Product code
- Code FAN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lancashire, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.