U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS— 510(k) K113036
Substantially EquivalentKimberly-Clark Corporation
FDA 510(k) clearance K113036 for U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS, Substantially Equivalent on 2011-11-02. 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
- Special
- Location
- Neenah, WI, US
Recent devices under product code HEB
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- K223749 — U by Kotex® Click® Unscented Menstrual Tampons
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- K200072 — KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
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.