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Porges Silicone Prostatectomy Catheter, Straight Cylindrical Tip, Delinotte Tip, Dufour Tip, Over the Guide Tip, Model

by Porges S.A.

510(k) K013172

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK013172 Date20 Dec 2001ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0845-2025 FDA Class II initiated 2 Dec 2024

    A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EZL
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Porges Silicone Prostatectomy Catheter is a medical device designed for use in prostatectomy procedures. It features a straight cylindrical tip with multiple tip options including Delinotte, Dour, and Over The Guide configurations. This catheter is classified as a retention type catheter and is intended for urological applications.

The device is supplied as a single-use item and is made of silicone material. It is MRI safe and has been cleared by the FDA under 510(k) K013172 as substantially equivalent. The catheter is manufactured by Porges S.A. in France and is regulated under product code EZL with FDA device class 2 classification.

Other devices from Porges S.A.

Questions

AI-generated answers, 23 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 is the Porges Silicone Prostatectomy Catheter used for?

    The Porges Silicone Prostatectomy Catheter is designed for use in prostatectomy procedures. It is a retention type catheter intended for urological applications, featuring a straight cylindrical tip with multiple configuration options including Delinotte, Dour, and Over The Guide tips.

  • Is the Porges Silicone Prostatectomy Catheter single-use or reusable?

    The Porges Silicone Prostatectomy Catheter is supplied as a single-use item. It is made of silicone material and is not intended for reuse, ensuring sterility and safety for each patient procedure.

  • What are the different tip options available for this catheter?

    The Porges Silicone Prostatectomy Catheter features a straight cylindrical tip with multiple tip configurations available, including Delinotte tip, Dour tip, and Over The Guide tip, allowing clinicians to select the most appropriate option for specific surgical needs.

  • Is the Porges Silicone Prostatectomy Catheter MRI safe?

    Yes, the Porges Silicone Prostatectomy Catheter is MRI safe, making it suitable for use in patients who may require magnetic resonance imaging during or after their prostatectomy procedure.

  • What is the regulatory status of the Porges Silicone Prostatectomy Catheter?

    The Porges Silicone Prostatectomy Catheter has been cleared by the FDA under 510(k) K013172 as substantially equivalent. It is classified as a Class 2 medical device under product code EZL and is manufactured by Porges S.A. in France.