# K232060: TOSAMA Reusable Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Tosama, D.O.O.
- Decided: Apr 12, 2024 after 276 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K180850 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212479: Cohitech Reusable Tampon Applicator, Cotton High Tech S.L. (2021) Summary page 4.

## Indications for use
The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.

Source page: https://510kreport.com/device/K232060
Methodology: https://510kreport.com/methodology