510(k) Report

FDA applicant

Bodywise (Uk), Ltd.

Bristol, Avon, GB2 decisions1993–19960 recalls

FDA records 2 decisions for Bodywise (Uk), Ltd. (Bristol, Avon, GB) from 1993 to 1996: 2 510(k) clearances. 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 Bodywise (Uk), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bodywise (Uk), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bodywise (Uk), Ltd.’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?

  • HEBTampon, Menstrual, Unscented2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K954942Natracaren Applicator TamponBodywise (Uk), Ltd. · 19961cites it
  • K914430Natracare TamponBodywise (Uk), Ltd. · 19931cites it

What has FDA decided for it lately?

  • K954942Natracaren Applicator TamponBodywise (Uk), Ltd. · 1996
  • K914430Natracare TamponBodywise (Uk), Ltd. · 1993

All 2 as Bodywise (Uk), Ltd. →