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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 4, 1995 | K945201 | COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT Cook, Inc. | ESW |
| Oct 3, 1994 | K940396 | WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) Boston Scientific Scimed, Inc. | ESW |
| Sep 20, 1994 | K940395 | WALLSTENT ESOPHAGEAL PROSTHESIS Boston Scientific Scimed, Inc. | ESW |
| Aug 18, 1994 | K940838 | MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM Boston Scientific Corp | ESW |
| Feb 9, 1994 | K920218 | ESOPHAGEAL Z-STENT Wilson-Cook Medical, Inc. | ESW |
| Sep 1, 1992 | K923119 | WALLSTENT ESOPHAGEAL PROTHESIS Schneider U.S. Stent Div. | ESW |
| Dec 9, 1991 | K914029 | ESOPHAGEAL Z-STENT Cook, Inc. | ESW |
| Jan 14, 1991 | K904821 | ELIACHAR MODIFIED ESOPHAGEAL STENT Hood Laboratories | ESW |
| Feb 9, 1990 | K885309 | WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS Wilson-Cook Medical, Inc. | ESW |
| Apr 13, 1987 | K871244 | HOOD ESOPHAGEAL PROSTHESIS Hood Laboratories | ESW |
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