510(k) Report

FDA applicant

Corisen Group, Ltd.

West Chester, OH1 decision2003–20030 recalls

FDA records 1 decision for Corisen Group, Ltd. (West Chester, OH) in 2003: 1 510(k) clearance. All are in product code HED (Douche Apparatus, Vaginal, Therapeutic). Its devices cite 2 predicates, 0 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 Corisen Group, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Corisen Group, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Corisen Group, Ltd.’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?

  • HEDDouche Apparatus, Vaginal, Therapeutic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K030056Worry-Remover IrrigatorCorisen Group, Ltd. · 2003

The one decision as Corisen Group, Ltd. →