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FDA 510(k)

CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED

K-Number: K132500 · 2013-12-23

ApplicantCure Medical, LLC
Decision Date2013-12-23
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED is the device name listed in this FDA 510(k) record. The listed applicant is Cure Medical, LLC. It received FDA 510(k) clearance on 2013-12-23 under 510(k) number K132500. 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 CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED is a medical device that received FDA 510(k) clearance on 2013-12-23. The listed applicant is Cure Medical, LLC. The 510(k) number is K132500.

When did CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED receive FDA 510(k) clearance?

CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED received FDA 510(k) clearance on 2013-12-23, under 510(k) number K132500.

Who is the listed applicant for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

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

What is the FDA product code for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

The FDA product code for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED is EZD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cure Medical, 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.

K110653CURE CATHETERK080881CURE CATHETER CLOSED SYSTEMK072539CURE CATHETER

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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