FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
K Number: K232262
·
Decision Nov 30, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
1
Review Days
122
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Basic Information
- Device Name
- LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
- K Number
- K232262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgease Innovations Limited
- Date Received
- July 31, 2023
- Decision Date
- November 30, 2023
- Product Code
- FAN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FAN | Sigmoidoscope, Rigid, Electrical | FDA class 2 | Gastroenterology, Urology |
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