510(k) K153633 ยท FTM Mesh, Surgical
Endoform Reconstructive Template
| Applicant | Aroa Biosurgery Limited (Formerly Mesynthes Limited), Auckland, NZ |
| Decision | Substantially Equivalent, Mar 15, 2016 |
| Received | Dec 18, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G Terminated |
FTM | None listed |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.