Cleared Traditional

Safety Wire Guide Introducer

K180756 · Cook Incorporated · Gastroenterology & Urology
May 2018
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K180756 is an FDA 510(k) clearance for the Safety Wire Guide Introducer, a Dilator, Catheter, Ureteral (Class II — Special Controls, product code EZN), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 24, 2018, 63 days after receiving the submission on March 22, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5470.

Submission Details

510(k) Number K180756 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2018
Decision Date May 24, 2018
Days to Decision 63 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
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · Coloplast Corp. · Jun 2020
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019
Ureteral Dilator Sets, Ureteral Dilators
K173654 · Cook Incorporated · Jul 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028 · Cook Incorporated · May 2018