# K101114: Advancis Activon Tube

- Pathway: 510(k) (Traditional)
- Applicant: Advancis Medical
- Decided: Jul 26, 2011 after 461 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: 5 generations back to K053095 (2007). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102478: Otc Elasto-Gel Manuka Honey Wound Dressing, Southwest Technologies, Inc. (2010). Cleared while this submission was under review Summary page 2.
- K092689: Manukapli Wound Dressing, Manuka Medical Limited (2010). Cleared while this submission was under review Summary page 1.
- K083334: Elasto-Gel Manuka Honey Wound Dressing, Southwest Technologies, Inc. (2009) Summary page 1.
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008) Summary page 1.
- K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008) Summary page 1.

## Indications for use
OTC: For minor wounds, minor ulcerations, minor bums, minor abraded skin, and minor irritated areas. Professional: Intended in the management of: * diabetic foot ulcers; * leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); * pressure ulcers/sores (partial and full thickness); * 1st and 2nd degree partial thickness bums; * grafted and donor sites and traumatic and surgical wounds.

Source page: https://510kreport.com/device/K101114
Methodology: https://510kreport.com/methodology