Cleared Traditional

In-Ka Ureteral Balloon Dilatation Catheter

K201007 · Coloplast Corp. · Gastroenterology & Urology
Jun 2020
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K201007 is an FDA 510(k) clearance for the In-Ka Ureteral Balloon Dilatation Catheter, a Dilator, Catheter, Ureteral (Class II — Special Controls, product code EZN), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on June 11, 2020, 55 days after receiving the submission on April 17, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5470.

Submission Details

510(k) Number K201007 FDA.gov
FDA Decision Cleared SESK
Date Received April 17, 2020
Decision Date June 11, 2020
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZN — Dilator, Catheter, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5470

Similar Devices — EZN Dilator, Catheter, Ureteral

All 55
Optilume? High Pressure Urological Balloon Dilation Catheter
K250910 · Urotronic, Inc. · May 2025
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
K220781 · Allwin Medical Devices, Inc. · May 2023
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019
Ureteral Dilator Sets, Ureteral Dilators
K173654 · Cook Incorporated · Jul 2018
Safety Wire Guide Introducer
K180756 · Cook Incorporated · May 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028 · Cook Incorporated · May 2018