# K984413: Bionect Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Pharmaceutical Corp.
- Decided: Feb 10, 1999 after 85 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.
60 later devices descend from it; 3 cite it directly.
1 of 64 devices in its family (counting itself) has 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
- K020325: L.a.M. Ipm Wound Gel (2002), 59 descendants of its own
- K090725: Oculus Microcyn Wound Gel (2009), 56 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own
- K123072: Vashe Wound Therapy Solution (2013), 25 descendants of its own
- K093585: Microcyn Skin and Wound Hydrogel (2010), 25 descendants of its own

## Indications for use
BIONECT® Hydrogel, Gauze Pads, Foam, Spray, and Clcar Hydrogel arc indicated for the dressing and management of minor burns: superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of these products to determine whether these conditions exist. BIONECT® Hydrogel, Gauze Pads, Foam, Spray, and Clcar Hyvdrogel may also be used under the carc of a health care professional for wounds such as partial 1o full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.

Source page: https://510kreport.com/device/K984413
Methodology: https://510kreport.com/methodology