# K240708: Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Borage Medical Technology Co., Ltd.
- Decided: May 10, 2024 after 56 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: 1 generation back to K222046 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222046: Unscented Menstrual Tampon, Suzhou Borage Medical Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K240708
Methodology: https://510kreport.com/methodology