# K250645: SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)

- Pathway: 510(k) (Traditional)
- Applicant: Haemoband Surgical, Ltd.
- Decided: Oct 9, 2025 after 219 days
- Product code: FER (Anoscope And Accessories)
- 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: 3 generations back to K993738 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070913: Self-Light Disposable Anoscope, Sapimed S.P.A. (2007) Summary page 5.

## Indications for use
SleeveLUX Anoscope/Proctoscope is a class 2 self-illuminating disposable instrument used to assist clinicians when treating and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids.

Source page: https://510kreport.com/device/K250645
Methodology: https://510kreport.com/methodology