FDA 510(k)

URETHRAL CATHETERIZATION TRAY

K-Number: K842866 · 1984-09-10

Decision Date1984-09-10

Product CodeKOD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URETHRAL CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Corp.. It received FDA 510(k) clearance on 1984-09-10 under 510(k) number K842866. 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 URETHRAL CATHETERIZATION TRAY?

URETHRAL CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1984-09-10. The listed applicant is Inmed Corp.. The 510(k) number is K842866.

When did URETHRAL CATHETERIZATION TRAY receive FDA 510(k) clearance?

URETHRAL CATHETERIZATION TRAY received FDA 510(k) clearance on 1984-09-10, under 510(k) number K842866.

Who is the listed applicant for URETHRAL CATHETERIZATION TRAY?

The FDA 510(k) record lists Inmed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URETHRAL CATHETERIZATION TRAY?

The FDA product code for URETHRAL CATHETERIZATION TRAY is KOD.

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Other records listing Inmed Corp. as applicant

K862672ESOPHAGEAL STETHOSCOPE WITH THERMISTOR K853162STERILE NASOPHARYNGEAL AIRWAY K850335URETEROSCOPY CATHETER K850152PRECONNECTED URETHRAL CATHETER TRAY K850248DISPOSABLE GUEDEL AIRWAY K844801ULTRA EXTERNAL CATHETER

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Related Devices (Code: KOD)

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.