# K123961: Sentrex Biosponge MPD

- Pathway: 510(k) (Traditional)
- Applicant: Bionova Medical, Inc.
- Decided: Apr 5, 2013 after 100 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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 K914579 (1992). 41 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112191: Healex Biosponge Wound Dressing, Bionova Medical, Inc. (2012) Summary page 1.
- K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing, Medline Industries, Inc. (2008) Summary page 1.
- K984371: Mepitel Non Adherent Silicone Dressing, Molnlycke Health Care, Inc. (1999) Summary page 1.
- K083113: Acticoat Flex 7 Dressing, Smith & Nephew, Inc. (2009) Summary page 1.
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.), Coloplast Corp. (2004) Summary page 1.
- K081635: Integra Meshed Bilayer Wound Matrix, Integra Lifesciences Corp. (2008) Summary page 1.

## Most influential descendants
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo (2022), 3 descendants of its own
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (2023), 2 descendants of its own
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (2024), 1 descendant of its own
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (2024), 0 descendants of its own

## Indications for use
The Sentrex BioSponge MPD is indicated in the dressing and management of: * Full thickness and partial thickness wounds * Pressure ulcers * Venous ulcers * Ulcers caused by mixed vascular etiologies * Diabetic ulcers * First and second degree burns * Donor sites and other bleeding surface wounds * Abrasions * Trauma wounds healing by secondary intention * Dehisced wounds * Surgical wounds * Dehisced surgical wounds * Grafts The Sentrex BioSponge MPD may be cut to size. The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).

Source page: https://510kreport.com/device/K123961
Methodology: https://510kreport.com/methodology