# K162721: Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

- Pathway: 510(k) (Special)
- Applicant: Alliqua Biomedical, Inc.
- Decided: Dec 22, 2016 after 84 days
- Product code: NRB (Wound Cleaner, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 878.4410
- 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 K140782 (2014). 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)
- K140782: Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator, Celleration, Inc. (2014) Summary page 4.

## Indications for use
MIST Systems produce a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.

Source page: https://510kreport.com/device/K162721
Methodology: https://510kreport.com/methodology