# K093227: Silverstream and Dermasept

- Pathway: 510(k) (Traditional)
- Applicant: Enzysurge, Ltd.
- Decided: Dec 10, 2009 after 57 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: 6 generations back to K914579 (1992). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 2.
- K063069: Silvaklenz Skin and Wound Clenser Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 2.

## Most influential descendants
- K200767: SilverStream Gel (2020), 0 descendants of its own

## Indications for use
SilverStreamn is intended for use under the supervision of a healthca re 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 bums, cuts abrasions and minor skin irritations DermaSept is intended for the management and moisturizing of minor cuts, minor bums, abrasions and irritated areas.

Source page: https://510kreport.com/device/K093227
Methodology: https://510kreport.com/methodology