# K180096: GDT-1000 System

- Pathway: 510(k) (Traditional)
- Applicant: Acuvu, Inc.
- Decided: Apr 16, 2018 after 90 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
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K211227: HTx Disposable Hysteroscope System (2021), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K180096
Methodology: https://510kreport.com/methodology