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FDA 510(k)

URETEROSCOPY CATHETER

K-Number: K850335 · 1985-03-12

ApplicantInmed Corp.
Decision Date1985-03-12
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETEROSCOPY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Corp.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K850335. 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 URETEROSCOPY CATHETER?

URETEROSCOPY CATHETER is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Inmed Corp.. The 510(k) number is K850335.

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

URETEROSCOPY CATHETER received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850335.

Who is the listed applicant for URETEROSCOPY CATHETER?

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 URETEROSCOPY CATHETER?

The FDA product code for URETEROSCOPY CATHETER is KOD.

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Other records listing Inmed Corp. 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.

K862672ESOPHAGEAL STETHOSCOPE WITH THERMISTORK853162STERILE NASOPHARYNGEAL AIRWAYK850152PRECONNECTED URETHRAL CATHETER TRAYK850248DISPOSABLE GUEDEL AIRWAYK844801ULTRA EXTERNAL CATHETERK842301DISPOSABLE LATEX BANDAGE

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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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