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FDA 510(k)

SELF CATH CATHETER

K-Number: K100878 · 2010-05-26

ApplicantColoplast Manufacturing Us, LLC
Decision Date2010-05-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SELF CATH CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Manufacturing Us, LLC. It received FDA 510(k) clearance on 2010-05-26 under 510(k) number K100878. 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 SELF CATH CATHETER?

SELF CATH CATHETER is a medical device that received FDA 510(k) clearance on 2010-05-26. The listed applicant is Coloplast Manufacturing Us, LLC. The 510(k) number is K100878.

When did SELF CATH CATHETER receive FDA 510(k) clearance?

SELF CATH CATHETER received FDA 510(k) clearance on 2010-05-26, under 510(k) number K100878.

Who is the listed applicant for SELF CATH CATHETER?

The FDA 510(k) record lists Coloplast Manufacturing Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF CATH CATHETER?

The FDA product code for SELF CATH CATHETER is EZD.

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Other records listing Coloplast Manufacturing Us, LLC 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.

K093112DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGEK082640VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEMK070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

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

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

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