U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS— 510(k) K112635
Substantially EquivalentKimberly-Clark Corp.
FDA 510(k) clearance K112635 for U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS, Substantially Equivalent on 2011-10-07. Applicant: Kimberly-Clark Corp.. Device class: 2.
Clearance details
- Applicant
- Kimberly-Clark Corp.
- 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
- Roswell, GA, US
Recent devices under product code HEB
view allMore clearances from Kimberly-Clark Corp.
view allAdverse 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 →
Recalls naming K112635
K-number listed on FDA's recall record- Z-0748-2019 — U by Kotex¿ Sleek¿, Regular Tampons, 18 Count
- Z-0749-2019 — U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
- Z-0750-2019 — U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack
- Z-0751-2019 — U by Kotex¿ Sleek¿, Regular Tampons, 3 Count
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112635.
Data sourced from openFDA. This site is unofficial and independent of the FDA.