510(k) Report

FDA applicant

Nvision Medical Corporation

Mountain View, CA2 decisions2015–20160 recalls

FDA records 2 decisions for Nvision Medical Corporation (Mountain View, CA) from 2015 to 2016: 2 510(k) clearances. All are in product code HIH (Hysteroscope (And Accessories)). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nvision Medical”.

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 Nvision Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Nvision Medical Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nvision Medical Corporation’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

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K160510MAKO 7Nvision Medical Corporation · 20161cites it
  • K151275MAKO DeviceNvision Medical · 20151cites it

What has FDA decided for it lately?

  • K160510MAKO 7Nvision Medical Corporation · 2016
  • K151275MAKO DeviceNvision Medical · 2015

The one decision as Nvision Medical Corporation →The one decision as Nvision Medical →

Other applicant names beginning “Nvision”

FDA records each applicant name separately; these may or may not be the same firm.

Nvision Biomedical Technologies, Inc. 40