# Acuvu, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 2 (2018–2021): 2 510(k) clearances
- Product codes: HIH (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Suzhou AcuVu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/suzhou-acuvu-medical-technology)
- Origyn Medical Technology (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/origyn-medical-technology-hangzhou)

## Its most-cited devices
- K211227: HTx Disposable Hysteroscope System (2021), cited by 2
- K180096: GDT-1000 System (2018), cited by 1

## Recent decisions
- K211227: HTx Disposable Hysteroscope System (Sep 15, 2021)
- K180096: GDT-1000 System (Apr 16, 2018)

Source page: https://510kreport.com/company/acuvu