510(k) K152070 ยท NEU Marker, Radiographic, Implantable
BioZorb LP Marker
| Applicant | Focal Therapeutics, Portola Valley CA, US |
| Decision | Substantially Equivalent, Aug 26, 2015 |
| Received | Jul 27, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2024 | Hologic, Inc BioZorb Marker. Radiographic soft tissue marker. Open, Classified |
NEU | None listed |
| May 3, 2024 | Hologic, Inc BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue.
1) F0405 BioZorb Marker 4cm x 5cm
2) F0404 BioZorb Marker 4cm x 4cm
3) F0331 BioZorb Marker 1c Open, Classified |
NEU | None listed |
| Sep 30, 2022 | Hologic, Inc The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component Open, Classified |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.