# K984368: Normlgel 0.9% Isotonic Saline Gel

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Feb 22, 1999 after 77 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) Normigel® Protective Wound Gel: named in the summary without a submission number

## Indications for use
Normlgel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.

Source page: https://510kreport.com/device/K984368
Methodology: https://510kreport.com/methodology