FDA Product Code
FDA Product Code MUM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3610
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2025-03-31 | Special | PDF ↗ |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023-06-14 | Traditional | PDF ↗ |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | Cook Ireland, Ltd. | 2017-05-04 | Traditional | PDF ↗ |
| K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | Cook Ireland, Ltd. | 2011-03-29 | Traditional | PDF ↗ |
| K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | Boston Scientific Corp | 2006-12-04 | Traditional | PDF ↗ |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-04-03 | Traditional | PDF ↗ |
Product code MUM · Class II · General, Plastic Surgery. Data: openFDA.