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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sigmoidoscope, Rigid, Electrical
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
Pendle Innovation Centre, Brook Street
Nelson
Lancashire,  GB BB9 9PU
Applicant Contact Roger Parker
Correspondent
SurgEase Innovations Limited
Pendle Innovation Centre, Brook Street
Nelson
Lancashire,  GB BB9 9PU
Correspondent Contact Roger Parker
Regulation Number876.1500
Classification Product Code
FAN  
Date Received07/31/2023
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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