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FDA 510(k)

Rusch Simplastic Foley Catheters

K-Number: K162989 · 2017-02-24

ApplicantTeleflexmedical, Inc.
Decision Date2017-02-24
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch Simplastic Foley Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162989. 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 Simplastic Foley Catheters?

Rusch Simplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162989.

When did Rusch Simplastic Foley Catheters receive FDA 510(k) clearance?

Rusch Simplastic Foley Catheters received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162989.

Who is the listed applicant for Rusch Simplastic Foley Catheters?

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

What is the FDA product code for Rusch Simplastic Foley Catheters?

The FDA product code for Rusch Simplastic Foley Catheters is EZL.

Other records listing Teleflexmedical, Inc. 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.

K232469Rüsch Latex Gold Foley CatheterK212077Teleflex Rusch SoftSimplastic Foley CathetersK192324Sheridan Spiral-Flex Endotracheal TubesK182847Hudson RCI Voldyne Volumetric ExerciserK181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterK183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

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Related Devices (Code: EZL)

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.

K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

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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