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FDA 510(k)

Rusch Silicone Foley Catheter

K-Number: K161770 · 2017-05-05

ApplicantTeleflexmedical, Inc.
Decision Date2017-05-05
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch Silicone Foley Catheter is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-05-05 under approval number K161770. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rusch Silicone Foley Catheter?

Rusch Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2017-05-05. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K161770.

When was Rusch Silicone Foley Catheter approved by the FDA?

Rusch Silicone Foley Catheter received FDA 510(k) clearance on 2017-05-05, under approval number K161770.

What company makes Rusch Silicone Foley Catheter?

Rusch Silicone Foley Catheter is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Rusch Silicone Foley Catheter?

The FDA product code for Rusch Silicone Foley Catheter is EZL.

Related Clinical Trials

NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT02932319 Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy COMPLETED NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING NCT07530328 Clinical Evaluation of Copesilcup COMPLETED

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K162396SILK Surgical Suture K161075Arrow Epidural Catheter Kit K153089'cottony' II TAPE, PLEDGETS K153010Hudson RCI AquaPak Sterile Prefilled Nebulizers K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL K153063PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM

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Related Devices (Code: EZL)

K153655Accuryn Monitoring SystemPotrero Medical, Inc. K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. K181616PSM 3-Way Silicone Foley CatheterPathway, LLC K180781Bard Vertus Foley CatheterC.R. Bard, Inc. K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. K173657Radiance(TM) Clear Sharklet(R) Silicone Foley CatheterCook Incorporated

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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