# K111382: Celver

- Pathway: 510(k) (Traditional)
- Applicant: Cellulose Concepts, LLC
- Decided: May 31, 2012 after 380 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013814 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002) Summary page 1.

## Indications for use
For over-the-counter use, CELVER® may be used for minor abrasions, minor lacerations, minor cuts, minor scalds and 1 st degree burns. For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).

Source page: https://510kreport.com/device/K111382
Methodology: https://510kreport.com/methodology