Last synced on 23 February 2024 at 11:04 pm

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232262
510(k) Type
Traditional
Applicant
SurgEase Innovations Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/30/2023
Days to Decision
122 days
Submission Type
Summary

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232262
510(k) Type
Traditional
Applicant
SurgEase Innovations Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/30/2023
Days to Decision
122 days
Submission Type
Summary