# K973538: N-Terface

- Pathway: 510(k) (Traditional)
- Applicant: Winfield Laboratories, Inc.
- Decided: Dec 16, 1997 after 89 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: 1 generation back to K820198 (1982). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820198: Derma-Aid, Winfield Laboratories, Inc. (1982) Summary page 1.

## Most influential descendants
- K992221: Acticoat Primary Antimicrobial Dressing (2000), 3 descendants of its own
- K011941: Excilon Amd Antimicrobial Sponge Model #7088 (2001), 1 descendant of its own
- K070685: Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 (2007), 0 descendants of its own
- K050086: Brennen Medical Silver Glucan Wound Dressing (2006), 0 descendants of its own
- K981713: Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 in. MODEL0 (1998), 0 descendants of its own

## Indications for use
N-TERFACE® Interpositional Surfacing Material is indicated for use as a wound contact layer for partial thickness burns as a result of the procedure of laser skin resurfacing.

Source page: https://510kreport.com/device/K973538
Methodology: https://510kreport.com/methodology