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FDA 510(k)

UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER

K-Number: K851684 · 1985-07-02

ApplicantUrotec Systems Corp.
Decision Date1985-07-02
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Urotec Systems Corp.. It received FDA 510(k) clearance on 1985-07-02 under 510(k) number K851684. 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 UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER?

UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER is a medical device that received FDA 510(k) clearance on 1985-07-02. The listed applicant is Urotec Systems Corp.. The 510(k) number is K851684.

When did UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER receive FDA 510(k) clearance?

UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER received FDA 510(k) clearance on 1985-07-02, under 510(k) number K851684.

Who is the listed applicant for UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER?

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

What is the FDA product code for UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER?

The FDA product code for UROTEC/FRANKLIN SOFT SIMPLASTIC 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.

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 Urotec Systems 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.

K854625UROTEC CLOSED IRRIGATIION SYRINGE

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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