# K232040: Gynatrof

- Pathway: 510(k) (Traditional)
- Applicant: Tyros Biopharma, Inc.
- Decided: Mar 1, 2024 after 235 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810310 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143349: Gynomunal, Polichem S.A (2015) Summary page 5.

## Indications for use
Gynatrof is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Gynatrof is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.

Source page: https://510kreport.com/device/K232040
Methodology: https://510kreport.com/methodology