# K094039: Hyalo Gyn

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Farmaceutici S.P.A.
- Decided: May 7, 2010 after 128 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: 3 generations back to K810310 (1981). 4 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072647: Glycerin & Paraben Free Astroglide, Biofilm, Inc. (2008) Summary page 1.

## Most influential descendants
- K150883: HyaloGYN Vaginal Hydrating Gel (2015), 9 descendants of its own
- K211998: Desnuda Reflect (2021), 6 descendants of its own
- K153372: Repagyn vaginal suppositories (2016), 4 descendants of its own
- K213220: Revaree Plus Vaginal Suppositories (2022), 3 descendants of its own
- K141718: Internal Hydrating Gel (2014), 2 descendants of its own

## Indications for use
HYALO GYN is a personal lubricant, or 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. This product is compatible with condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin..

Source page: https://510kreport.com/device/K094039
Methodology: https://510kreport.com/methodology