# K964701: Mitraflex Pigmented Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Polymedica Industries, Inc.
- Decided: Feb 7, 1997 after 74 days
- Product code: FRO (Dressing, Wound, Drug)
- 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) MITRAFLEX Wound Dressings, Wet-Stick: named in the summary without a submission number
- (no number) MITRAFLEX Wound Dressings: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K964701
Methodology: https://510kreport.com/methodology