# K071703: Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic

- Pathway: 510(k) (Traditional)
- Applicant: Swiss American Products, Inc.
- Decided: Aug 22, 2007 after 62 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082333: Asap Wound Dressing Gel (2009), 6 descendants of its own
- K092826: Asap Antimicrobial Silver Wound Dressing Gel (2009), 2 descendants of its own
- K140483: Asap Otc Wound Dressing Gel (2014), 1 descendant of its own
- K131176: Ross RU Skin Discontinuities (2014), 1 descendant of its own
- K073019: Silvermed Antimicrobial Silver Hydrogel (2008), 1 descendant of its own

## Indications for use
Elta Silver Antimicrobial Wound Gel is indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Source page: https://510kreport.com/device/K071703
Methodology: https://510kreport.com/methodology