# K153372: Repagyn vaginal suppositories

- Pathway: 510(k) (Traditional)
- Applicant: Farma-Derma S.R.L.
- Decided: Jun 30, 2016 after 220 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: 4 generations back to K810310 (1981). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094039: Hyalo Gyn, Fidia Farmaceutici S.P.A. (2010) Summary page 5.

## Most influential descendants
- K213220: Revaree Plus Vaginal Suppositories (2022), 3 descendants of its own
- K261909: Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (2026), 0 descendants of its own
- K260007: Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (2026), 0 descendants of its own
- K230518: HydraDose Vaginal Suppositories (2023), 0 descendants of its own

## Indications for use
Repagyn is a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K153372
Methodology: https://510kreport.com/methodology