# K981713: Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 in. MODEL0

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 31, 1998 after 77 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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: 2 generations back to K820198 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973538: N-Terface, Winfield Laboratories, Inc. (1997) Summary page 2.
- (no number) 3M Tegapore™ Wound Contact Material: named in the summary without a submission number
- (no number) DERMANET™ Wound Contact Layer: named in the summary without a submission number
- (no number) Conformant 2™ Transparent, Non-Adherent, Wound Veil: named in the summary without a submission number
- (no number) TELFA CLEAR™ Nonadherent Wound Dressing: named in the summary without a submission number

## Indications for use
Wound contact layer dressings are indicated to provide covering for the wound bed. For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including Abrasions Skin tears Minor burns and scalds Under the care of a healthcare professional, CicaNet* Wound Contact Layer Dressing may be used in the management of partial and full thickness wounds including: Leg ulcers Pressure ulcers Second degree burns Surgical wounds Diabetic foot ulcers

Source page: https://510kreport.com/device/K981713
Methodology: https://510kreport.com/methodology