510(k) K163468
- Device
- Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
- Applicant
- Cook Ireland Ltd.
- 510(k) number
- K163468
- Product code
- MUM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-04
- Date received
- 2016-12-12
- Regulation
- 878.3610
- Classification name
- Stent, Metallic, Expandable, Duodenal
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jacinta Kilmartin
- Address
- O' Halloran Rd., National Technology Park Limerick IE
FDA Registration Numbers#
- 3001845648
- 3040096051
- 3010173425
- 3005580113
- 3011458193
- 3003902943
- 3009526575
- 3008146331
- 3010273872
- 3005099803
- 1000121056
- 9681260
- 3002807314
Source Documents#
Other 510(k) Records For Product Code MUM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2025-03-31 |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023-06-14 |
| 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 |
| K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | Boston Scientific Corp | 2006-12-04 |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-04-03 |
Legacy Summary#
summary
FDA Review#
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