# K071371: Copa Amd Antimicrobial Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare Group LP
- Decided: Nov 19, 2007 after 187 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.
21 later devices descend from it; 2 cite it directly.
0 of 22 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) COPA (Curafoam) polyurethane foam wound dressings: named in the summary without a submission number
- (no number) Kerlix AMID: named in the summary without a submission number
- (no number) Excilon AMID: named in the summary without a submission number

## Most influential descendants
- K111940: S 100 Pedicle Screw System (2012), 19 descendants of its own
- K162764: Jazz Frame System (2017), 6 descendants of its own
- K170730: JAZZ System, including JAZZ Band (2017), 5 descendants of its own
- K222097: OLYMPIC Deformity Band System (2023), 3 descendants of its own
- K173180: Mega Plus Spine System (2018), 3 descendants of its own

## Indications for use
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

Source page: https://510kreport.com/device/K071371
Methodology: https://510kreport.com/methodology