FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U by Kotex® Click® Unscented Menstrual Tampons
K Number: K223749
·
Decision Jan 6, 2023
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
11
Review Days
23
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Basic Information
- Device Name
- U by Kotex® Click® Unscented Menstrual Tampons
- K Number
- K223749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kimberly-Clark Corporation
- Date Received
- December 14, 2022
- Decision Date
- January 6, 2023
- Product Code
- HEB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Kimberly-Clark Corporation
| K Number | Device Name | ||
|---|---|---|---|
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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 | Apr 10, 2020 | Substantially Equivalent |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | Oct 11, 2017 | Substantially Equivalent |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Dec 2, 2014 | Substantially Equivalent |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | Jun 9, 2014 | Substantially Equivalent |
| K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES | Jun 26, 2013 | Unknown |
| K120650 | POISE PERSONAL LUBRICANT | Jul 11, 2012 | Substantially Equivalent |
| K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | May 11, 2012 | Substantially Equivalent |
| K113036 | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS | Nov 2, 2011 | Substantially Equivalent |