# K963004: Bionect Cream

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Pharmaceutical Corp.
- Decided: Feb 12, 1997 after 194 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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 K830708 (1983). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945835: Argidene (TM) Gel, Telios Pharmaceuticals, Inc. (1995) Summary page 2.
- K902345: Carrington Wound Dressing, Carrington Laboratories, Inc. (1990) Summary page 2.
- K830708: Duo Derm Flex Hydroactive Dressings &, Convatec, A Division of E.R. Squibb & Sons (1983) Summary page 2.

## Most influential descendants
- K172747: Hyaluronic Acid Topical Wound Cream (2018), 0 descendants of its own
- K984262: Modification of Bionect Hydrogel Gauze Pads (1999), 0 descendants of its own

## Indications for use
BIONECT® Cream is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.

Source page: https://510kreport.com/device/K963004
Methodology: https://510kreport.com/methodology