Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GOOSEN SELF-LUBRICATING CATHETER

K-Number: K923848 · 1994-02-18

ApplicantGoosen Enterprises, Inc.
Decision Date1994-02-18
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GOOSEN SELF-LUBRICATING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Goosen Enterprises, Inc.. It received FDA 510(k) clearance on 1994-02-18 under 510(k) number K923848. 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 GOOSEN SELF-LUBRICATING CATHETER?

GOOSEN SELF-LUBRICATING CATHETER is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Goosen Enterprises, Inc.. The 510(k) number is K923848.

When did GOOSEN SELF-LUBRICATING CATHETER receive FDA 510(k) clearance?

GOOSEN SELF-LUBRICATING CATHETER received FDA 510(k) clearance on 1994-02-18, under 510(k) number K923848.

Who is the listed applicant for GOOSEN SELF-LUBRICATING CATHETER?

The FDA 510(k) record lists Goosen Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOOSEN SELF-LUBRICATING CATHETER?

The FDA product code for GOOSEN SELF-LUBRICATING CATHETER 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 Goosen Enterprises, Inc. 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.

K896134ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.K896579GOOSEN URINARY DRAINAGE SYSTEMK844889MENSINK-GOOSEN 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

View on FDA Database →

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

↑