Ureteral Dilators and Percutaneous Nephrostomy Dilators— 510(k) K170531
Substantially EquivalentColoplast Corp.
FDA 510(k) clearance K170531 for Ureteral Dilators and Percutaneous Nephrostomy Dilators, Substantially Equivalent on 2017-08-17. Applicant: Coloplast Corp.. Device class: 2.
Clearance details
- Applicant
- Coloplast Corp.
- Product code
- Code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code EZN
view all- K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter
- K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- K201007 — In-Ka Ureteral Balloon Dilatation Catheter
- K190612 — EQUINOX Balloon Dilatation Catheter
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
More clearances from Coloplast Corp.
view allAdverse events under product code EZN
product code EZN- Death
- 3
- Injury
- 127
- Total
- 130
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 K170531
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 K170531.
Data sourced from openFDA. This site is unofficial and independent of the FDA.