PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
FDA 510(k) clearance K013172 · decided 2001-12-20
Clearance details
- K-number
- K013172
- Device name
- PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
- Applicant
- Porges S.A.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-24
- Decision date
- 2001-12-20
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Le Plessis Robinson Cedex, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB recall (Z-0845-2025) | Coloplast Manufacturing US, LLC | 2025-01-10 |