Data / Medical devices / United Kingdom / Surgease Innovations Ltd
Surgease Innovations Ltd: FDA-registered device maker in Berkshire England, United Kingdom, 1 510(k) clearance
Surgease Innovations Ltd is registered with the FDA (registration 3038293255) in Berkshire England, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038293255
- Address
- SurgEase Innovations Ltd First floor Burlington house 1-13 York Road, Berkshire England, United Kingdom, SL6 1SQ
- Owner or operator
- Surgease innovations ltd (10093836)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 19, 2025
- Registered through
- 2026
- Brand names listed
- LumenEye X1, SESIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sigmoidoscope, Rigid, Electrical | FAN | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 30, 2023 | K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | FAN | Substantially Equivalent | Surgease Innovations Limited | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.