MODIFICATION TO URETERAL STENT
FDA 510(k) clearance K040760 · decided 2004-10-15
Clearance details
- K-number
- K040760
- Device name
- MODIFICATION TO URETERAL STENT
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-25
- Decision date
- 2004-10-15
- Days to decision
- 204 days
- Clearance type
- Special
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24 recall (Z-2219-2008) | Applied Medical Resources Corp | 2008-09-16 |
| SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x 26 recall (Z-2220-2008) | Applied Medical Resources Corp | 2008-09-16 |
| SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22 recall (Z-2221-2008) | Applied Medical Resources Corp | 2008-09-16 |
| SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F mult recall (Z-2222-2008) | Applied Medical Resources Corp | 2008-09-16 |
| SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F mult recall (Z-2223-2008) | Applied Medical Resources Corp | 2008-09-16 |
| SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x 26 recall (Z-2224-2008) | Applied Medical Resources Corp | 2008-09-16 |