NATRACARE TAMPON— 510(k) K914430

Name: FDA 510(k) clearance K914430
Creator: U.S. Food and Drug Administration
Published: 1993-09-03

Substantially Equivalent

Bodywise (Uk), Ltd.

FDA 510(k) clearance K914430 for NATRACARE TAMPON, Substantially Equivalent on 1993-09-03. Applicant: Bodywise (Uk), Ltd.. Device class: 2.

Clearance details

Applicant: Bodywise (Uk), Ltd.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1991-10-04
Decision date: 1993-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, Avon, GB

Download summary PDF View on FDA.gov ↗

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K954942 — NATRACAREN APPLICATOR TAMPON1996-01-25

Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.