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FDA 510(k)

UROLOGICAL CATHETER

K-Number: K011552 · 2001-07-18

ApplicantApogee Medical, Inc.
Decision Date2001-07-18
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGICAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Apogee Medical, Inc.. It received FDA 510(k) clearance on 2001-07-18 under 510(k) number K011552. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROLOGICAL CATHETER?

UROLOGICAL CATHETER is a medical device that received FDA 510(k) clearance on 2001-07-18. The listed applicant is Apogee Medical, Inc.. The 510(k) number is K011552.

When did UROLOGICAL CATHETER receive FDA 510(k) clearance?

UROLOGICAL CATHETER received FDA 510(k) clearance on 2001-07-18, under 510(k) number K011552.

Who is the listed applicant for UROLOGICAL CATHETER?

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

What is the FDA product code for UROLOGICAL CATHETER?

The FDA product code for UROLOGICAL CATHETER is GBM.

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 Apogee Medical, 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.

K032710CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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