# K982597: Fibrcol Plus Collagen Wound Dressing with Alginate

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Aug 20, 1998 after 27 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: 1 generation back to K881854 (1988). 3 ancestors in all.
253 later devices descend from it; 8 cite it directly.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925548: Fibracol Collagen-Alginate Dressing, Johnson & Johnson Medical, Inc. (1993) Summary page 1.
- K881854: Sorbsan Topical Wound Dressing, E.G. Dick & Assoc. (1988) Summary page 1.
- K914575: Sorbsan Topical Wound Dressing (Modified), Dow B. Hickam, Inc. (1991) Summary page 1.

## Most influential descendants
- K993948: Sis Wound Dressing II (2000), 235 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own
- K014129: Promogran Matrix Wound Dressing (2002), 77 descendants of its own

## Indications for use
FIBRACOL* PLUS Dressing is indicated for the management of exuding wounds including: Full thickness & partial thickness wounds Pressure Ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Second-degree burns Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical incisions Precautions: FIBRACOL PLUS Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. FIBRACOL PLUS Dressing may be used under compression therapy with healthcare profession supervision. Contraindications: FIBRACOL PLUS is not indicated for wounds with active vasculitis, third-degree burns, or patients with known sensitivity to collagen or alginates.

Source page: https://510kreport.com/device/K982597
Methodology: https://510kreport.com/methodology