# K984264: Modification of Bionect Clear 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
No predicates in its family tree.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BIONECT® Hydrogel: named in the summary without a submission number

## Most influential descendants
- K080010: Nocc Hydrophilic Wound Dressing (2008), 21 descendants of its own
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own
- K092689: Manukapli Wound Dressing (2010), 10 descendants of its own
- K112191: Healex Biosponge Wound Dressing (2012), 5 descendants of its own
- K123961: Sentrex Biosponge MPD (2013), 4 descendants of its own

## Indications for use
BIONECT® Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel are 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 Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to 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/K984264
Methodology: https://510kreport.com/methodology