# K963623: Spyroflex Pigmented Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Polymedica Industries, Inc.
- Decided: Oct 25, 1996 after 44 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 Wound Dressings, Wet-Stick: named in the summary without a submission number
- (no number) SPYROFLEX Wound Dressings: named in the summary without a submission number
- (no number) Flexzan Topical Wound Dressings: named in the summary without a submission number

## Indications for use
SPYROFLEX Pigmented Wound Dressings are intended for use in the management of: Venous stasis ulcers Partial-thickness wounds Diabetic ulcers Superficial burns Pressure sores Abrasions and lacerations Donor sites Full-thickness wounds Blisters Skin tears Incisions Dermal lesions Severe sunburn Minor chemical burns Poison Ivy Thermal burns Dermabrasions and other dermatologic procedures Facelifts and other plastic surgery procedures (e.g. laser resurfacing)

Source page: https://510kreport.com/device/K963623
Methodology: https://510kreport.com/methodology