510(k) K113872 ยท KNW Instrument, Biopsy
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
| Applicant | Vidacare Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 8, 2012 |
| Received | Dec 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113872
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2021 | Arrow International Inc Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)
Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended Open, Classified |
KNW | None listed |
| Nov 8, 2016 | Teleflex Medical ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions. Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.