# K162508: KerraCel Ag Gelling Fiber Silver Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Exciton Technologies, Inc.
- Decided: Feb 13, 2017 after 158 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914604 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 5.

## Most influential descendants
- K222740: Venus Ag 120, 160, 200  2x2 inch, Venus Ag 120, 160, 200  4x4 inch, Venus Ag 120, 160, 200  4x5 inch, Venus Ag 120, 160, 200  6x6 inch,Venus Ag 120, 160, 200  1x18 inch (2024), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1807-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi

## Indications for use
Under the supervision of a healthcare professional, KerraGel Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.

Source page: https://510kreport.com/device/K162508
Methodology: https://510kreport.com/methodology