510(k) K232262
K232262 is an FDA 510(k) premarket notification submitted by Surgease Innovations Limited for the device "LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )". The FDA issued a decision of Substantially Equivalent on November 30, 2023. The device falls under product code FAN (Sigmoidoscope, Rigid, Electrical), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2023
- Date Received
- July 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sigmoidoscope, Rigid, Electrical
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type