# K160379: Exufiber Ag+

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Aug 25, 2016 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: 5 generations back to K914604 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec, Inc. (2012) Summary page 4.

## Indications for use
For over-the-counter use, Exufiber Ag+ may be used for: • Abrasions • Lacerations • Minor cuts • Minor scalds and burns Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds: • Leg ulcers (venous stasis ulcers, arterial ulcers and ulcers of mixed etiology) and diabetic foot ulcers • Pressure ulcers (partial and full thickness) • Partial thickness burns • Donor sites and other wounds that are prone to bleeding, such as debrided wounds • Traumatic wounds • Surgical wounds that heal by primary intention, such as dermatological and surgical incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions • Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi’s sarcoma and angiosarcoma Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection. Indicated wear time: up to seven (7) days.

Source page: https://510kreport.com/device/K160379
Methodology: https://510kreport.com/methodology