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510(k) K212479

Cohitech Reusable Tampon Applicator by Cotton High Tech S.L. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
August 9, 2021
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 Cotton High Tech S.L.

  • K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (October 9, 2025)
  • K220238 — Cohitech Cottonlock Tampons with Reusable Applicator (February 25, 2022)
  • K211775 — Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (October 22, 2021)
  • K182813 — COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT (March 15, 2019)
  • K152284 — COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGAN (December 4, 2015)
  • K091084 — MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS (April 29, 2009)

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)