# K072560: Envela (Hydrohesive Occlusive Dressing)

- Pathway: 510(k) (Traditional)
- Applicant: Teikoku Pharma USA, Inc.
- Decided: Jun 17, 2008 after 280 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DuoDerm® Extra Thin (Extra Thin® CGF Dressing): named in the summary without a submission number
- (no number) Compeed Psoriasis Dressing: named in the summary without a submission number
- (no number) Hydrocolloid Dressing for Psoriasis: named in the summary without a submission number

## Indications for use
-For use in the management of psoriasis and the protection of psoriatic plaques -As a protective dressing - For management of superficial, dry to lightly exudating dermal wounds.

Source page: https://510kreport.com/device/K072560
Methodology: https://510kreport.com/methodology