# K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing

- Pathway: 510(k) (Abbreviated)
- Applicant: Medline Industries, Inc.
- Decided: Apr 25, 2008 after 324 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
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112191: Healex Biosponge Wound Dressing (2012), 5 descendants of its own
- K123961: Sentrex Biosponge MPD (2013), 4 descendants of its own
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo (2022), 3 descendants of its own
- K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (2016), 3 descendants of its own
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (2023), 2 descendants of its own

## Indications for use
Puracol® Plus Ag MicroScaffold TM Wound Dressing is indicated for the management of: Full thickness and partial thickness wounds Pressure ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree bums Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds These dressings may be cut to size and may be layered for the management of deep wounds.

Source page: https://510kreport.com/device/K071552
Methodology: https://510kreport.com/methodology