# K973725: Bionect Clear Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Pharmaceutical Corp.
- Decided: Sep 22, 1998 after 357 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K172338: Catasyn Advanced Technology Wound Hydrogel (2018), 0 descendants of its own

## Indications for use
BIONECT® Clear Hydrogel 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.

Source page: https://510kreport.com/device/K973725
Methodology: https://510kreport.com/methodology