# K090432: Hemorpex System

- Pathway: 510(k) (Traditional)
- Applicant: Angiologica B. M. Srl
- Decided: May 29, 2009 after 99 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 2.

## Indications for use
The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.

Source page: https://510kreport.com/device/K090432
Methodology: https://510kreport.com/methodology