# K082296: Copa Amd

- Pathway: 510(k) (Traditional)
- Applicant: Covidien Lp, Formerly Registered AS Tyco Healthcar
- Decided: Feb 26, 2009 after 198 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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 AMD antimicrobial wound dressing: named in the summary without a submission number

## Most influential descendants
- K160872: PolyPlex Wound Dressing (2016), 4 descendants of its own
- K181315: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (2019), 1 descendant of its own
- K221755: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (2023), 0 descendants of its own
- K201016: LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) (2021), 0 descendants of its own
- K183681: Protego Antimicrobial Wound Dressing (2019), 0 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/K082296
Methodology: https://510kreport.com/methodology