510(k) Report

FDA applicant

Sanpoint AB

Mariefred, SE1 decision1996–19960 recalls

FDA records 1 decision for Sanpoint AB (Mariefred, SE) in 1996: 1 510(k) clearance. All are in product code HEB (Tampon, Menstrual, Unscented). 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 Sanpoint AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sanpoint AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sanpoint AB 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?

  • HEBTampon, Menstrual, Unscented1decision

What has FDA decided for it lately?

  • K961926Sanpoint Menstrual TamponSanpoint AB · 1996

The one decision as Sanpoint AB →