# K073246: Zenieva

- Pathway: 510(k) (Traditional)
- Applicant: Gorbec Pharmaceutical Services, Inc.
- Decided: Jul 23, 2008 after 247 days
- Product code: NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)
- Device class: 1
- Regulation: 21 CFR 878.4022
- 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 K961758 (1996). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041342: Impruv a.I. Cream Wound and Skin Emulsion, Stiefel Laboratories, Inc. (2005) Summary page 1.

## Most influential descendants
- K090337: Tropazone Lotion (2009), 3 descendants of its own
- K082865: Modification to Zenieva (2008), 2 descendants of its own
- K093544: Tropazone CR (2010), 1 descendant of its own
- K083721: Modification to Zenieva (2009), 1 descendant of its own
- K162217: LOYON (2017), 0 descendants of its own

## Indications for use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Source page: https://510kreport.com/device/K073246
Methodology: https://510kreport.com/methodology