# K193085: PuraDERM Gel

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: May 11, 2020 after 188 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: 3 generations back to K894541 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143058: PuraDerm Gel, 3-D Matrix, Inc. (2015) Summary page 4.
- K991202: Modification to Woun'dres, Coloplast Corp. (1999) Summary page 4.

## Indications for use
PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

Source page: https://510kreport.com/device/K193085
Methodology: https://510kreport.com/methodology