510(k) K112635
K112635 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS". The FDA issued a decision of Substantially Equivalent on October 7, 2011. The device falls under product code HEB (Tampon, Menstrual, Unscented), a Class II device regulated under 21 CFR 884.5470. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2011
- Date Received
- September 9, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tampon, Menstrual, Unscented
- Device Class
- Class II
- Regulation Number
- 884.5470
- Review Panel
- OB
- Submission Type
An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.