# K981150: Solosite Gel Conformable Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 22, 1998 after 83 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
Longest line of descent: 1 generation back to K933495 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935096: Biolex Impregnated Wound Dressing, C.R. Bard, Inc. (1994) Summary page 2.
- K962218: Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDG, Carrington Laboratories, Inc. (1996) Summary page 2.
- K933495: MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads), Marketing Professionals IN Medicine, Inc. (1994) Summary page 2.
- (no number) Restore™ Hydrogel Impregnated Sponge: named in the summary without a submission number

## Most influential descendants
- K122297: Enluxtra Humifiber Wound Dressing (2012), 0 descendants of its own

## Indications for use
SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as: Minor burns Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of: Venous ulcers (leg ulcers) Surgical incisions Diabetic foot ulcers Pressure ulcers (including stage IV). Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.

Source page: https://510kreport.com/device/K981150
Methodology: https://510kreport.com/methodology