510(k) Report

FDA applicant

Gillette Children'S Specialty Healthcare

Eagan, MN1 decision2000–20000 recalls

FDA records 1 decision for Gillette Children'S Specialty Healthcare (Eagan, MN) in 2000: 1 510(k) clearance. All are in product code MVA (Orthosis, Cranial). 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, neurology panel, where it files most

How often FDA has decided Gillette Children'S Specialty Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gillette Children'S Specialty Healthcare since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gillette Children'S Specialty Healthcare by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MVAOrthosis, Cranial1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K000861CraniocapGillette Children'S Specialty Healthcare · 20001cites it

What has FDA decided for it lately?

  • K000861CraniocapGillette Children'S Specialty Healthcare · 2000

The one decision as Gillette Children'S Specialty Healthcare →

Other applicant names beginning “Gillette”

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

The Gillette Company 3