# K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Jul 20, 2018 after 232 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.
4 later devices descend from it; 4 cite it directly.
0 of 12 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 5.

## Most influential descendants
- K252167: Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (2025), 0 descendants of its own
- 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
- K231953: Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) (2024), 0 descendants of its own
- K213473: Antimicrobial Gelling Fiber Dressing with PHMB (2023), 0 descendants of its own

## Indications for use
AQUACEL™ Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber may be used for the management of: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional; AQUACEL™ Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; - Partial thickness (second degree) burns; - Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; - Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular); - Traumatic wounds; - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; - Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi’s sarcoma, and angiosarcoma; - Management of painful wounds; - Infected wounds

Source page: https://510kreport.com/device/K173675
Methodology: https://510kreport.com/methodology