# K974520: Spyroflex Foam Island Wound Dressing, Spyroflex Foam Island Wound Dressing, Tinted, Spyrofoam

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies (Us), Inc.
- Decided: Feb 6, 1998 after 66 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) SPYROFLEX Pigmented Wound Dressings: named in the summary without a submission number
- (no number) Tielle Hydropolymer Dressings: named in the summary without a submission number

## Indications for use
SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites Blisters Incisions Severe sunbum Poison Ivy Partial-thickness wounds Superficial burns Abrasions and lacerations Full-thickness wounds Skin tears Dermal lesions Minor chemical burns Thermal bumns SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions Superficial Blisters Minor Burns Superficial Cuts Superficial Lacerations Superficial Scrapes Minor Rash

Source page: https://510kreport.com/device/K974520
Methodology: https://510kreport.com/methodology