# K982804: Spyrogel Hydrogel Wound and Burn Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies (Us), Inc.
- Decided: Dec 16, 1998 after 128 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) Spenco’s 2nd Skin Moist Burn Pads: named in the summary without a submission number
- (no number) Johnson and Johnson’s Nu-Gel: named in the summary without a submission number

## Indications for use
The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns and scalds

Source page: https://510kreport.com/device/K982804
Methodology: https://510kreport.com/methodology