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)

MENSINK-GOOSEN CATHETER

K-Number: K844889 · 1985-03-18

ApplicantGoosen Enterprises, Inc.
Decision Date1985-03-18
Product CodeGBP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENSINK-GOOSEN 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 1985-03-18 under 510(k) number K844889. The device is classified under product code GBP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENSINK-GOOSEN CATHETER?

MENSINK-GOOSEN CATHETER is a medical device that received FDA 510(k) clearance on 1985-03-18. The listed applicant is Goosen Enterprises, Inc.. The 510(k) number is K844889.

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

MENSINK-GOOSEN CATHETER received FDA 510(k) clearance on 1985-03-18, under 510(k) number K844889.

Who is the listed applicant for MENSINK-GOOSEN 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 MENSINK-GOOSEN CATHETER?

The FDA product code for MENSINK-GOOSEN CATHETER is GBP.

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.

K923848GOOSEN SELF-LUBRICATING CATHETERK896134ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.K896579GOOSEN URINARY DRAINAGE SYSTEM

Related Devices (Code: GBP)

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.

K821220MULTILUMEN INTRAVENOUS INFUSION CATHETERClincal Instruments Corp.K820446CATHETER, MULTIPLE LUMENDlp, Inc.

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.

↑