LumenEye® X1 endoscope (LX1-SCP-203) +2 more— 510(k) K232262

Name: FDA 510(k) clearance K232262
Creator: U.S. Food and Drug Administration
Published: 2023-11-30

Substantially Equivalent

Surgease Innovations Limited

FDA 510(k) clearance K232262 for LumenEye® X1 endoscope (LX1-SCP-203) +2 more, Substantially Equivalent on 2023-11-30. Applicant: Surgease Innovations Limited. Device class: 2.

Clearance details

Device name as filed: 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
Product code: Code FAN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-31
Decision date: 2023-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancashire, GB

Download summary PDF View on FDA.gov ↗

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