# K200767: SilverStream Gel

- Pathway: 510(k) (Traditional)
- Applicant: Enzysurge, Ltd.
- Decided: Oct 8, 2020 after 197 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 7 generations back to K914579 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093227: Silverstream and Dermasept, Enzysurge, Ltd. (2009) Summary page 4.

## Indications for use
SilverStream Gel is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second-degree burns, cuts abrasions and minor skin irritations. SilverStream Gel is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.

Source page: https://510kreport.com/device/K200767
Methodology: https://510kreport.com/methodology