510(k) K252892 ยท NEU Marker, Radiographic, Implantable
SCOUT MD Surgical Guidance System
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Sep 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Merit Medical Systems, Inc. Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01
Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO Open, Classified |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.