510(k) Report

FDA applicant

Acuvu, Inc.

Redwood City, CA2 decisions2018–20210 recalls

FDA records 2 decisions for Acuvu, Inc. (Redwood City, CA) from 2018 to 2021: 2 510(k) clearances. All are in product code HIH (Hysteroscope (And Accessories)). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Acuvu, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12021: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Acuvu, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acuvu, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HIHHysteroscope (And Accessories)2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211227HTx Disposable Hysteroscope SystemAcuvu, Inc. · 20212cite it
  • K180096GDT-1000 SystemAcuvu, Inc. · 20181cites it

What has FDA decided for it lately?

  • K211227HTx Disposable Hysteroscope SystemAcuvu, Inc. · 2021
  • K180096GDT-1000 SystemAcuvu, Inc. · 2018

All 2 as Acuvu, Inc. →