PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X— 510(k) K013921
Substantially EquivalentPorges S.A.
FDA 510(k) clearance K013921 for PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X, Substantially Equivalent on 2002-10-17. Applicant: Porges S.A.. Device class: 2.
Clearance details
- Applicant
- Porges S.A.
- Product code
- Code FAD
- Device class
- Class 2
- Regulation
- 21 CFR 876.4620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Plessis Robinson Cedex, FR
Recent devices under product code FAD
view allMore clearances from Porges S.A.
view all- K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
- K013174 — PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
- K013172 — PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
Adverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.