# K984266: Modification of Bionect Hydrogel Spray

- 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.
No later device cites it as a predicate yet.
0 of 1 device 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

## 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/K984266
Methodology: https://510kreport.com/methodology