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FDA 510(k)

K-KATH URETHRAL CATHETER INTRODUCER

K-Number: K802878 · 1981-01-02

ApplicantB&K Medical
Decision Date1981-01-02
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

K-KATH URETHRAL CATHETER INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is B&K Medical. It received FDA 510(k) clearance on 1981-01-02 under 510(k) number K802878. 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 K-KATH URETHRAL CATHETER INTRODUCER?

K-KATH URETHRAL CATHETER INTRODUCER is a medical device that received FDA 510(k) clearance on 1981-01-02. The listed applicant is B&K Medical. The 510(k) number is K802878.

When did K-KATH URETHRAL CATHETER INTRODUCER receive FDA 510(k) clearance?

K-KATH URETHRAL CATHETER INTRODUCER received FDA 510(k) clearance on 1981-01-02, under 510(k) number K802878.

Who is the listed applicant for K-KATH URETHRAL CATHETER INTRODUCER?

The FDA 510(k) record lists B&K Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-KATH URETHRAL CATHETER INTRODUCER?

The FDA product code for K-KATH URETHRAL CATHETER INTRODUCER 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 B&K Medical 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.

K943315ULTRASOUND SCANNER 2002K926332DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIEDK933056DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED

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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