# K082865: Modification to Zenieva

- Pathway: 510(k) (Special)
- Applicant: Gorbec Pharmaceutical Services, Inc.
- Decided: Oct 23, 2008 after 24 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: 4 generations back to K961758 (1996). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073246: Zenieva, Gorbec Pharmaceutical Services, Inc. (2008) Summary page 1.

## Most influential descendants
- K083721: Modification to Zenieva (2009), 1 descendant of its own
- K100839: Barirep (2010), 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/K082865
Methodology: https://510kreport.com/methodology