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FDA 510(k)

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER

K-Number: K050008 · 2005-06-03

ApplicantMentor Corp.
Decision Date2005-06-03
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 2005-06-03 under 510(k) number K050008. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER?

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER is a medical device that received FDA 510(k) clearance on 2005-06-03. The listed applicant is Mentor Corp.. The 510(k) number is K050008.

When did MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER receive FDA 510(k) clearance?

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER received FDA 510(k) clearance on 2005-06-03, under 510(k) number K050008.

Who is the listed applicant for MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER?

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 HYDROGEL INTERMITTENT CATHETER?

The FDA product code for MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER is EZD.

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Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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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