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FDA 510(k)

URETHRAL CATHETER

K-Number: K800505 · 1980-04-08

ApplicantMedi-Craft , Ltd.
Decision Date1980-04-08
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Craft , Ltd.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800505. 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 CATHETER?

URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Medi-Craft , Ltd.. The 510(k) number is K800505.

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

URETHRAL CATHETER received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800505.

Who is the listed applicant for URETHRAL CATHETER?

The FDA 510(k) record lists Medi-Craft , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URETHRAL CATHETER?

The FDA product code for URETHRAL CATHETER 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.

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Other records listing Medi-Craft , Ltd. 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.

K861949SUCTION CATHETER KITK800507FEEDING TUBESK800508STOMACH TUBESK800510RECTAL & HARRIS FLUSH TUBESK800506OXYGEN CATHETERK800509CONNECTING TUBES

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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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