# K143058: PuraDerm Gel

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Feb 13, 2015 after 112 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 K894541 (1989). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973806: Duoderm Hydroactive Gel, Convatec, A Bristol-Myers Squibb Co. (1997) Summary page 4.
- K991202: Modification to Woun'dres, Coloplast Corp. (1999) Summary page 4.

## Most influential descendants
- K182681: AC5 Topical Gel (2018), 1 descendant of its own
- K193085: PuraDERM Gel (2020), 0 descendants of its own
- K190129: AC5 Topical Gel (2020), 0 descendants of its own

## Indications for use
OTC: PuraDerm is used for the management of minor cuts, abrasions, minor wounds and minor burns (1st degree burns). Rx: Under the supervision of a health care professional PuraDerm is used for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

Source page: https://510kreport.com/device/K143058
Methodology: https://510kreport.com/methodology