LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
Surgease Innovations Limited
SURGEASE INNOVATIONS LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3038293255 | 3038293255 | SURGEASE INNOVATIONS LTD | 1 | N | 2026-01-01 | SurgEase Innovations Ltd First floor Burlington house 1-13 York Road Berkshire England GB SL6 1SQ |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 341870 | 1760446864 | K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | FAN | 2023-11-30 |
| 341870 | 1008092623 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FAN | 1 | 2023-11-30 |
PMN#
GUDID#
Consumable Pack (Sheath, Obturator, Manifold & Camera Cover) - Consumable Pack used with LumenEye X1
2026-05-13
Consumable Pack (Sheath, Obturator & Manifold) - Consumables to be used with LumenEye X1
2026-05-13
LumenEye X1 Scope - A portable digital rectoscope enabling rapid, real-time colorectal diagnosis.
2026-05-13
Large LumenEye x1 Manifold -26mm - Large Manifold to be used with LumenEye X1
2026-05-13
Large LumenEye x1 Manifold -30mm - Large Manifold to be used with LumenEye X1
2026-05-13
SESIS - Single-use endoscopic suction and irrigation set intended for anorectal endoscopic procedures with compatible endoscopic systems. The device facilitates controlled irrigation and suction to assist visualization during procedures.
2026-05-09