K122603 is an FDA 510(k) clearance for the ONTEX AND OTHER PROPRIETARY NAMES. This device is classified as a Tampon, Menstrual, Unscented (Class II - Special Controls, product code HEB).
Submitted by Ontex Bvba (Old Lyme, US). The FDA issued a Cleared decision on December 19, 2012, 114 days after receiving the submission on August 27, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5470. 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..
| 510(k) Number | K122603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2012 |
| Decision Date | December 19, 2012 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEB - Tampon, Menstrual, Unscented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5470 |
| Definition | 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. |