510(k) Report

FDA applicant

Rovers B.V.

Rockaway, NJ2 decisions1994–19950 recalls

FDA records 2 decisions for Rovers B.V. (Rockaway, NJ) from 1994 to 1995: 2 510(k) clearances. All are in product code HHT (Spatula, Cervical, Cytological). 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 Rovers B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rovers B.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rovers B.V. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • HHTSpatula, Cervical, Cytological2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K930955Cervex-BrushRovers B.V. · 19943cite it

What has FDA decided for it lately?

  • K933870Viba-BrushRovers B.V. · 1995
  • K930955Cervex-BrushRovers B.V. · 1994

All 2 as Rovers B.V. →

Other applicant names beginning “Rovers”

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

Rovers Medical Devices B.V. 3Rovers Diagnostic Devices 3