WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
FDA 510(k) clearance K062750 · decided 2006-12-04
Clearance details
- K-number
- K062750
- Device name
- WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2006-09-14
- Decision date
- 2006-12-04
- Days to decision
- 81 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
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D (K101530) | Cook Ireland, Ltd. | 2011-03-29 |
| WALLSTENT ENTERAL ENDOPROSTHESIS (K980113) | Boston Scientific Scimed, Inc. | 1998-04-03 |
Recalls involving this device
No recalls on record reference this clearance.