EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
FDA 510(k) clearance K101530 · decided 2011-03-29
Clearance details
- K-number
- K101530
- Device name
- EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- Applicant
- Cook Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-03
- Decision date
- 2011-03-29
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- MUM
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Limerick, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (K250663) | Taewoong Medical Co., Ltd. | 2025-03-31 |
| Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (K223067) | Taewoong Medical Co., Ltd. | 2023-06-14 |
| Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468) | Cook Ireland, Ltd. | 2017-05-04 |
| WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 (K062750) | Boston Scientific Corp | 2006-12-04 |
| WALLSTENT ENTERAL ENDOPROSTHESIS (K980113) | Boston Scientific Scimed, Inc. | 1998-04-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zilver Flex® 35 Vascular Stent (P050017/S025) | Cook Ireland, Ltd. | 2025-10-22 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| Zilver Flex(R) 35 Vascular Stent (P050017/S024) | Cook Ireland, Ltd. | 2025-07-01 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Zilver® PTX® Peripheral Drug- Eluting Stent (P100022/S042) | Cook Ireland, Ltd. | 2023-09-22 |