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FDA 510(k)

MENTOR SELF-CATH PLUS

K-Number: K003784 · 2001-03-05

ApplicantMentor Corp.
Decision Date2001-03-05
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR SELF-CATH PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 2001-03-05 under 510(k) number K003784. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR SELF-CATH PLUS?

MENTOR SELF-CATH PLUS is a medical device that received FDA 510(k) clearance on 2001-03-05. The listed applicant is Mentor Corp.. The 510(k) number is K003784.

When did MENTOR SELF-CATH PLUS receive FDA 510(k) clearance?

MENTOR SELF-CATH PLUS received FDA 510(k) clearance on 2001-03-05, under 510(k) number K003784.

Who is the listed applicant for MENTOR SELF-CATH PLUS?

The FDA 510(k) record lists Mentor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR SELF-CATH PLUS?

The FDA product code for MENTOR SELF-CATH PLUS is EZL.

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Other records listing Mentor Corp. as applicant

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.

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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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