# K984370: Hypergel 20% Hypertonic Saline Gel

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Mar 1, 1999 after 84 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) Hypergel® - 20% Hypertonic Protective Wound Gel: named in the summary without a submission number

## Indications for use
Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.

Source page: https://510kreport.com/device/K984370
Methodology: https://510kreport.com/methodology