# K083334: Elasto-Gel Manuka Honey Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Southwest Technologies, Inc.
- Decided: Jul 30, 2009 after 260 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: 2 generations back to K053095 (2007). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872165: Elasto-Gel Occlusive Dressing, Southwest Technologies, Inc. (1987) Summary page 1.
- K072956: Medihoney Primary Dressings with Active Manuka Honey, Derma Sciences, Inc. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K053395: BP Pro Blood Pressure Monitor, Card Guard Scientific Survival, Ltd. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K182725: Apis (2019), 2 descendants of its own
- K102478: Otc Elasto-Gel Manuka Honey Wound Dressing (2010), 1 descendant of its own
- K222143: Apis (R), Veris (TM) (2023), 0 descendants of its own
- K211972: Omeza Collagen Matrix (2021), 0 descendants of its own
- K101114: Advancis Activon Tube (2011), 0 descendants of its own

## Indications for use
Elasto-gel Manuka Honey wound Dressings are indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers, (stages 1-IV) venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds, and surgical wounds

Source page: https://510kreport.com/device/K083334
Methodology: https://510kreport.com/methodology