PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL— 510(k) K013172
Substantially EquivalentPorges S.A.
FDA 510(k) clearance K013172 for PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL, Substantially Equivalent on 2001-12-20. Applicant: Porges S.A.. Device class: 2.
Clearance details
- Applicant
- Porges S.A.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Le Plessis Robinson Cedex, FR
Recent devices under product code EZL
view allMore clearances from Porges S.A.
view all- K013921 — PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
- 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,
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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 →
Recalls naming K013172
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013172.
Data sourced from openFDA. This site is unofficial and independent of the FDA.