Panels › General, Plastic Surgery › Product code ESW · Class 2
Prosthesis, Esophageal
Regulation 878.3610
1510(k)s in 12 months (60 all time)
0recalls in 12 months (67 all time)
67recalls that name a 510(k)
Top companies in ESW
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 15 | 65 |
| Taewoong Medical | 8 | 1 |
| M.I.Tech Co., Ltd. | 6 | 0 |
| Wilson-Cook Medical, Inc. | 3 | 1 |
| Alveolus, Inc. | 3 | 0 |
| Cook Ireland, Ltd. | 3 | 0 |
| Boston Scientific Scimed, Inc. | 2 | 0 |
| Cook, Inc. | 2 | 0 |
| Hood Laboratories | 2 | 0 |
| Instent, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/7. Catalog Number M00513800. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lum Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/15/12. Catalog Number M00513750. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lum Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/12/9. Catalog Number M00513740. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/10/7. Catalog Number M00513730. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/10. Catalog Number M00513710. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/7. Catalog Number M00513700. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumin Terminated |
ESW | K032930 |
| Aug 26, 2004 | Wilson-Cook Medical Inc Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethan Terminated |
ESW | K920218 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 150mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 120mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 90mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 23/18mm x 150mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 23/18mm x 120mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 23/18mm x 90mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 20/16mm x 150mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 20/16mm x 120mm Terminated |
ESW | K010068 |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 20/16mm x 90mm Terminated |
ESW | K010068 |
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