RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
FDA 510(k) clearance K010068 · decided 2001-02-08
Clearance details
- K-number
- K010068
- Device name
- RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-08
- Decision date
- 2001-02-08
- Days to decision
- 31 days
- Clearance type
- Abbreviated
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jaffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Polyflex Esophageal Stent 20/16mm x 90mm recall (Z-0818-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 20/16mm x 120mm recall (Z-0819-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 20/16mm x 150mm recall (Z-0820-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 23/18mm x 90mm recall (Z-0821-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 23/18mm x 120mm recall (Z-0822-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 23/18mm x 150mm recall (Z-0823-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 25/21mm x 90mm recall (Z-0824-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 25/21mm x 120mm recall (Z-0825-03) | Boston Scientific Corporation | 2003-05-14 |
| Polyflex Esophageal Stent 25/21mm x 150mm recall (Z-0826-03) | Boston Scientific Corporation | 2003-05-14 |