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FDA 510(k)

Rüsch Latex Gold Foley Catheter

K-Number: K232469 · 2024-08-01

ApplicantTeleflexmedical, Inc.
Decision Date2024-08-01
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rüsch Latex Gold Foley Catheter is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2024-08-01 under approval number K232469. 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 Rüsch Latex Gold Foley Catheter?

Rüsch Latex Gold Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K232469.

When was Rüsch Latex Gold Foley Catheter approved by the FDA?

Rüsch Latex Gold Foley Catheter received FDA 510(k) clearance on 2024-08-01, under approval number K232469.

What company makes Rüsch Latex Gold Foley Catheter?

Rüsch Latex Gold Foley Catheter is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Rüsch Latex Gold Foley Catheter?

The FDA product code for Rüsch Latex Gold 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

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Related Devices (Code: EZL)

K153655Accuryn Monitoring SystemPotrero Medical, Inc. K161770Rusch Silicone Foley CatheterTeleflexmedical, 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.

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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