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Balloon Catheter and Balloon Ureteral Dilator Set

by Cook Incorporated

510(k) K172588

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172588↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK 510(k) Substantially Equivalent — Kit · Traditional NumberK172588 Date19 Apr 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
EZN
Device Class
Class II
Regulation
21 CFR Part 876.5470
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Balloon Catheter and Balloon Ureteral Dilator Set, classified as a dilator, catheter, ureteral under regulatory nomenclature. It combines a balloon catheter and a dilator designed to facilitate controlled dilation of the ureter, aiding in procedures such as ureteroscopy or stone manipulation. The set includes radiopaque markers to ensure precise positioning within the ureteral anatomy.

The set is intended for single-use in clinical settings, including urology and gastroenterology. It is supplied sterile and requires no additional preparation beyond standard aseptic techniques. The device is regulated under FDA 510K and MDR, with multiple FEI numbers corresponding to various sizes and configurations. Storage should follow manufacturer guidelines to maintain sterility and functionality.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties primarily use this Balloon Catheter and Balloon Ureteral Dilator Set, and why is it relevant to those fields?

    This set is primarily used in urology and gastroenterology procedures. It is designed to facilitate controlled dilation of the ureter, which is critical during interventions like ureteroscopy or stone manipulation—common procedures in urology. In gastroenterology, it may assist in related endoscopic procedures requiring ureteral access or dilation, though its primary focus remains ureteral applications.

  • Is this device intended for reuse, or is it meant to be used only once? How does that affect its handling?

    The device is intended for single-use only, as explicitly stated in the description. This means it must be discarded after one procedure to maintain sterility and safety. Clinicians should follow standard single-use protocols, including proper disposal and avoiding reuse, to prevent contamination and ensure compliance with regulatory requirements.

  • How do I know if the correct size or model is being used for a specific patient, and what sizes are available?

    The set comes in multiple sizes and configurations, as indicated by the FEI numbers (e.g., 3006546082, 3013557562, etc.) and product codes. While exact measurements aren’t listed here, the radiopaque markers included in the set help ensure precise positioning during procedures. Always verify the selected size against the patient’s anatomy and consult the manufacturer’s guidelines or packaging for compatibility before use.

  • What steps should I take to ensure the device remains sterile and functional before use?

    The device is supplied sterile and requires no additional preparation beyond standard aseptic techniques. Storage must follow the manufacturer’s instructions to preserve sterility and functionality. Avoid exposing the packaging to moisture, extreme temperatures, or physical damage, as these could compromise the device’s integrity before use.

  • What regulatory pathways does this device follow, and how does that affect its use in clinical settings?

    This device is regulated under FDA 510K clearance and the EU Medical Device Regulation (MDR). The Gastroenterology and Urology (GU) Advisory Committee reviewed its submission, confirming its classification as a Class II device under FDA regulations (device class=2). While these pathways ensure safety and efficacy, they do not alter clinical use—only the manufacturer’s instructions and standard aseptic practices apply to its application in procedures.