# K040314: Healicoll

- Pathway: 510(k) (Traditional)
- Applicant: Encoll Corp.
- Decided: Aug 12, 2004 after 185 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: 3 generations back to K881854 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913023: Skintemp, Biocore (1991) Summary page 1.
- K910944: Medifil, Biocore (1991) Summary page 1.
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001) Summary page 1.
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 1.
- K925548: Fibracol Collagen-Alginate Dressing, Johnson & Johnson Medical, Inc. (1993) Summary page 1.
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- (no number) hyCurcO Advanced Collagen Wound Care: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K003721: Modification to Olympus AU2700 Clinical Chemistry Analyzer, Olympus America, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Healicoll Topical Collagen Wound Dressing is intended for the topical wound management that includes: * Partial and full-thickness wounds. * Pressure ulcers. * Venous ulcers. * Chronic vascular ulcers. * Diabetic ulcers. * Trauma wounds (abrasions, lacerations, second-degree burns, skin tears), * Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

Source page: https://510kreport.com/device/K040314
Methodology: https://510kreport.com/methodology