510(k) K232262
- Device
- LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
- Applicant
- Surgease Innovations Limited
- 510(k) number
- K232262
- Product code
- FAN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-30
- Date received
- 2023-07-31
- Regulation
- 876.1500
- Classification name
- Sigmoidoscope, Rigid, Electrical
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Roger Parker
- Address
- Pendle Innovation Centre, Brook St. Nelson Lancashire GB BB9 9PU BB9 9PU
FDA Registration Numbers#
- 3038293255
Source Documents#
Other 510(k) Records For Product Code FAN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831788 | URODYNAMIC ANALYZER | C.R. Bard, Inc. | 1983-09-12 |