WallFlex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730
510(k) K091510
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091510 | Date26 Jun 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ESW
- FDA applicant
- Boston Scientific Corporation
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3610
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The WallFlex Esophageal Fully Covered Stent System is a prosthesis designed for esophageal use. It is a fully covered stent intended to restore and maintain esophageal luminal patency in patients with strictures caused by intrinsic or extrinsic malignant tumors, including those with concurrent esophageal fistulas.
This device is supplied as a sterile, single-use system and is classified as a Class II medical device under FDA regulations (21 CFR 878.3610). It is intended for use in clinical settings where endoscopic procedures are performed. The system is available in multiple models, each with distinct dimensions, and requires FDA-cleared 510(k) authorization for use in the United States. No MRI safety information is specified in the provided data.
Other devices from Boston Scientific
Questions
AI-generated answers, 1 Oct 2026
What is the WallFlex Esophageal Fully Covered Stent System used for?
This stent system is designed to restore and maintain esophageal luminal patency in patients with strictures caused by intrinsic or extrinsic malignant tumors. It is also indicated for use in patients with esophageal fistulas, helping to improve passage through the esophagus while addressing complications from tumors.
How is the WallFlex Esophageal Fully Covered Stent System supplied?
The system is supplied as a sterile, single-use device. This ensures safety and reduces the risk of cross-contamination between patients, making it ideal for clinical settings where endoscopic procedures are performed.
Is the WallFlex Esophageal Fully Covered Stent System reusable?
No, the WallFlex Esophageal Fully Covered Stent System is intended for single-use only. Single-use devices are designed to minimize infection risks and ensure consistent performance for each patient procedure.
What models are available for the WallFlex Esophageal Fully Covered Stent System?
The system is available in multiple models, specifically M00516700, M00516710, M00516720, and M00516730. Each model likely corresponds to distinct dimensions to accommodate varying patient anatomies and clinical needs.
What regulatory authorization does the WallFlex Esophageal Fully Covered Stent System have?
The WallFlex Esophageal Fully Covered Stent System holds FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device. This authorization allows it to be legally marketed and used in the United States under the specified indications.