# K211227: HTx Disposable Hysteroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Acuvu, Inc.
- Decided: Sep 15, 2021 after 145 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: 1 generation back to K180096 (2018). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180096: GDT-1000 System, Acuvu, Inc. (2018) Summary page 4.

## Most influential descendants
- K240401: ClearVision Single Use Hysteroscope  & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) (2024), 0 descendants of its own
- K231260: HTx Disposable Hysteroscope System (2024), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K211227
Methodology: https://510kreport.com/methodology