# K231260: HTx Disposable Hysteroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou AcuVu Medical Technology Co., Ltd.
- Decided: Mar 5, 2024 after 309 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K180096 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211227: HTx Disposable Hysteroscope System, Acuvu, Inc. (2021) Summary page 5.

## Indications for use
HTx Disposable Hysteroscope System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. Note: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves a method of surgery.

Source page: https://510kreport.com/device/K231260
Methodology: https://510kreport.com/methodology