510(k) K162508 ยท FRO Dressing, Wound, Drug
KerraCel Ag Gelling Fiber Silver Dressing
| Applicant | Exciton Technologies, Inc., Edmonton, CA |
| Decision | Substantially Equivalent, Feb 13, 2017 |
| Received | Sep 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158 Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.