# K240401: ClearVision Single Use Hysteroscope  & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

- Pathway: 510(k) (Traditional)
- Applicant: Origyn Medical Technology (Hangzhou) Co., Ltd.
- Decided: Jul 26, 2024 after 168 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
ClearVision Single Use Hysteroscope & Image Processing System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (EHS-Dx4001) or diagnostic and operative procedures (EHS-Op5001 and EHS-Op6001).

Source page: https://510kreport.com/device/K240401
Methodology: https://510kreport.com/methodology