LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
FDA 510(k) clearance K232262 · decided 2023-11-30
Clearance details
- K-number
- K232262
- Device name
- 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
- Decision
- Substantially Equivalent
- Date received
- 2023-07-31
- Decision date
- 2023-11-30
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- FAN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lancashire, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| URODYNAMIC ANALYZER (K831788) | C.R. Bard, Inc. | 1983-09-12 |
Recalls involving this device
No recalls on record reference this clearance.