# K232262: LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables  (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

- Pathway: 510(k) (Traditional)
- Applicant: Surgease Innovations Limited
- Decided: Nov 30, 2023 after 122 days
- Product code: FAN (Sigmoidoscope, Rigid, Electrical)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770291 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770291: Sigmoidoscope, Disposable, Model #53125, Welch Allyn, Inc. (1977) Summary page 6.

## Indications for use
The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required. The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults. The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.

Source page: https://510kreport.com/device/K232262
Methodology: https://510kreport.com/methodology