# K980673: Spyrosorb Foam Island Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies (Us), Inc.
- Decided: May 21, 1998 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.
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) Mitraflex 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
Spyrosorb Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of partial and full thickness wounds. The following indications for use are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers; Burns, Minor and Chemical Diabetic ulcers; Abrasions and lacerations Pressure sores; Incisions Donor sites The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns

Source page: https://510kreport.com/device/K980673
Methodology: https://510kreport.com/methodology