# K171855: External Moisturizing Gel

- Pathway: 510(k) (Special)
- Applicant: Combe Incorporated
- Decided: Jul 21, 2017 after 30 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)
- K141718: Internal Hydrating Gel, Combe Incorporated (2014) Summary page 4.
- K150615: Vaginal Moisturizing Gel, Combe Incorporated (2015) Summary page 4.

## Indications for use
The device 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. This product is compatible with natural rubber and polyisoprene condoms. Not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K171855
Methodology: https://510kreport.com/methodology