U by Kotex® Click® Unscented Menstrual Tampons— 510(k) K223749
Substantially EquivalentKimberly-Clark Corporation
FDA 510(k) clearance K223749 for U by Kotex® Click® Unscented Menstrual Tampons, Substantially Equivalent on 2023-01-06. Applicant: Kimberly-Clark Corporation. Device class: 2.
Clearance details
- Applicant
- Kimberly-Clark Corporation
- Product code
- Code HEB
- Device class
- Class 2
- Regulation
- 21 CFR 884.5470
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Neenah, WI, US
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Adverse events under product code HEB
product code HEB- Injury
- 329
- Malfunction
- 5,647
- Total
- 5,976
Source: openFDA MAUDE database, through . 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.