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FDA 510(k)

CURE CATHETER CLOSED SYSTEM

K-Number: K080881 · 2008-06-11

ApplicantCure Medical, LLC
Decision Date2008-06-11
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CURE CATHETER CLOSED SYSTEM 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 2008-06-11 under 510(k) number K080881. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURE CATHETER CLOSED SYSTEM?

CURE CATHETER CLOSED SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-11. The listed applicant is Cure Medical, LLC. The 510(k) number is K080881.

When did CURE CATHETER CLOSED SYSTEM receive FDA 510(k) clearance?

CURE CATHETER CLOSED SYSTEM received FDA 510(k) clearance on 2008-06-11, under 510(k) number K080881.

Who is the listed applicant for CURE CATHETER CLOSED SYSTEM?

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 CLOSED SYSTEM?

The FDA product code for CURE CATHETER CLOSED SYSTEM is KOD.

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.

K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDK110653CURE CATHETERK072539CURE CATHETER

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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