ESOPHAGEAL Z-STENT
FDA 510(k) clearance K920218 · decided 1994-02-09
Clearance details
- K-number
- K920218
- Device name
- ESOPHAGEAL Z-STENT
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-16
- Decision date
- 1994-02-09
- Days to decision
- 755 days
- Clearance type
- Traditional
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Spe recall (Z-1410-04) | Wilson-Cook Medical Inc | 2004-08-26 |