# K971337: Epitech Island Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Rynel, Ltd. Inc.
- Decided: Jul 9, 1997 after 90 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rynel Medical Foam: named in the summary without a submission number

## Most influential descendants
- K990042: Silon Dual-Dress (1999), 0 descendants of its own

## Indications for use
The Rynel Epitech™ Island Dressing is intended for use in the local management of surgical incisions, lacerations, trauma inflicted wounds, abrasions, superficial burns, secondary dressings for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect the skin from potential irritation, maceration and to manage exudate.

Source page: https://510kreport.com/device/K971337
Methodology: https://510kreport.com/methodology