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FDA 510(k)

DOVER ROB-NEL CATHETER

K-Number: K040897 · 2004-07-20

ApplicantTyco Healthcare
Decision Date2004-07-20
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOVER ROB-NEL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare. It received FDA 510(k) clearance on 2004-07-20 under 510(k) number K040897. 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 DOVER ROB-NEL CATHETER?

DOVER ROB-NEL CATHETER is a medical device that received FDA 510(k) clearance on 2004-07-20. The listed applicant is Tyco Healthcare. The 510(k) number is K040897.

When did DOVER ROB-NEL CATHETER receive FDA 510(k) clearance?

DOVER ROB-NEL CATHETER received FDA 510(k) clearance on 2004-07-20, under 510(k) number K040897.

Who is the listed applicant for DOVER ROB-NEL CATHETER?

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

What is the FDA product code for DOVER ROB-NEL CATHETER?

The FDA product code for DOVER ROB-NEL CATHETER is KOD.

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Other records listing Tyco Healthcare 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.

K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSORK070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662K061492MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGEK042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETERK040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE

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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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