Panels › General, Plastic Surgery › Product code MUM · Class 2
Stent, Metallic, Expandable, Duodenal
Regulation 878.3610
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MUM
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Ireland, Ltd. | 2 | 0 |
| Taewoong Medical Co., Ltd. | 2 | 0 |
| Boston Scientific Corp | 1 | 0 |
| Boston Scientific Scimed, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2025 | K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent Taewoong Medical Co., Ltd., KR | MUM |
| Jun 14, 2023 | K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent Taewoong Medical Co., Ltd., KR | MUM |
| May 4, 2017 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered Cook Ireland, Ltd., IE | MUM |
| Mar 29, 2011 | K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D Cook Ireland, Ltd., IE | MUM |
| Dec 4, 2006 | K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 Boston Scientific Corp | MUM |
| Apr 3, 1998 | K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. | MUM |
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