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FDA 510(k)

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER

K-Number: K946243 · 1995-02-13

ApplicantColoplast A/S
Decision Date1995-02-13
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K946243. The device is classified under product code EXJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER?

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Coloplast A/S. The 510(k) number is K946243.

When did CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER receive FDA 510(k) clearance?

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1995-02-13, under 510(k) number K946243.

Who is the listed applicant for CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER?

The FDA product code for CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER is EXJ.

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Other records listing Coloplast A/S as applicant

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Related Devices (Code: EXJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970465BOUSER'S URINALGeneral PolymersK972100VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)Advanced Care Medical ProductsK970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERSierra Laboratories, Inc.K963265PROSYS SAMEC LAConvatec, A Division of E.R. Squibb & SonsK962900SELF RETAINING MALE EXTERNAL URINARY CATHETERHollister, Inc.K962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERSierra Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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