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Conveen Self-Sealing Urisheath Male External Catheter

by Coloplast A/S

510(k) K946243

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 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K946243↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK946243 Date13 Feb 1995ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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)

Full name
Conveen(R) Self-Sealing Urisheath Male External Catheter
510(k) Number
FDA Product Code
EXJ
Device Class
Class I
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Conveen Self-Sealing Urisheath Male External Catheter is a sterile, single-use incontinence device classified as an external urosheath. Designed for male patients, it provides a non-invasive urinary drainage solution by adhering to the penis and collecting urine in an attached collection bag, reducing the risk of leakage and skin irritation.

This device is supplied sterile and intended for single-use applications in clinical and homecare settings. It is manufactured without natural rubber latex and features a self-sealing mechanism to prevent urine leakage. The product is authorised under FDA 510(k) clearance and EU MDR compliance, with a product code of EXJ. Sizes and variants are listed under registration numbers 9612030, 2938651, and others, adhering to regulatory standards for incontinence management.

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Questions

AI-generated answers, 19 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 primary purpose of the Conveen Self-Sealing Urisheath Male External Catheter, and how does it differ from traditional external catheters?

    The Conveen Self-Sealing Urisheath is designed as a non-invasive urinary drainage solution specifically for male patients experiencing incontinence. Unlike traditional external catheters, it features a self-sealing mechanism to prevent urine leakage, reducing the risk of skin irritation and mess. It adheres directly to the penis, collecting urine in an attached bag, making it ideal for clinical or homecare settings where ease of use and reliability are critical.

  • Is this device latex-free, and what does that mean for patients with sensitivities?

    Yes, the Conveen Self-Sealing Urisheath is manufactured without natural rubber latex, which is important for patients with latex allergies or sensitivities. This ensures a safer option for those who may experience adverse reactions to latex-containing medical devices, minimizing the risk of allergic responses during use.

  • How many sizes or variants are available, and what registration numbers correspond to them?

    The device comes in multiple sizes and variants, each corresponding to specific registration numbers for regulatory tracking: 9612030, 2938651, 3001650535, 3005273623, 3042277801, 9613418, 1423537, 3009308092, 3003965134, 3008489813, and 1921846. These variants allow for tailored fit and comfort across different patient anatomies, ensuring optimal performance for male users.

  • Is the Conveen Self-Sealing Urisheath intended for reuse, or is it strictly single-use?

    The device is intended for single-use only, as explicitly stated in its design and regulatory submission. This ensures hygiene and safety, as reuse could compromise sterility and increase infection risks. Each unit is pre-sterilized for immediate clinical or homecare application, adhering to best practices for incontinence management.

  • What regulatory pathways does this device follow, and which committees were involved in its evaluation?

    The Conveen Self-Sealing Urisheath was evaluated under the FDA 510(k) clearance process, classified as substantially equivalent to prior devices. Its submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its dual relevance to both specialties. Additionally, it complies with EU MDR (Medical Device Regulation), ensuring alignment with European standards for incontinence management devices.