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510(k) K162746

Ontex and other proprietary names by Ontex Bvba — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2017
Date Received
September 30, 2016
Clearance Type
Traditional
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.

Other clearances by Ontex Bvba

  • K191666 — Unscented W long plastic and cardboard applicator tampons (December 20, 2019)
  • K142786 — Ontex Unscented Tampons with Colored Plastic Applicators (June 23, 2015)
  • K132595 — ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS (April 23, 2014)
  • K132208 — ONTEX AND OTHERS PROPRIETARY NAMES (April 10, 2014)
  • K122603 — ONTEX AND OTHER PROPRIETARY NAMES (December 19, 2012)

Other clearances for product code HEB

  • K253719 — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applic (December 17, 2025)
  • K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (October 9, 2025)
  • K252613 — Unscented menstrual three-piece applicator tampon (September 19, 2025)
  • K251033 — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicat (August 13, 2025)
  • K242105 — SABA Tampons (April 1, 2025)
  • K241064 — Unscented Tampon (January 10, 2025)
  • K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (May 10, 2024)
  • K232060 — TOSAMA Reusable Applicator (April 12, 2024)
  • K232598 — Unscented Menstrual Tampon (December 15, 2023)
  • K223883 — Daye Tampon (August 18, 2023)