# K260007: Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

- Pathway: 510(k) (Traditional)
- Applicant: Hudi Pharma Srl
- Decided: Apr 1, 2026 after 89 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213220: Revaree Plus Vaginal Suppositories, Farma-Derma S.R.L. (2022) Summary page 5.

## Indications for use
The Hyaluronic Acid Vaginal Suppository (HA 5 mg) and Hyaluronic Acid Vaginal Suppository (HA 10 mg) are personal lubricants designed for vaginal application to moisturize and lubricate, enhancing comfort and ease during intimate sexual activity, and supplementing the body’s natural lubrication. This product is not compatible with condoms.

Source page: https://510kreport.com/device/K260007
Methodology: https://510kreport.com/methodology