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FDA 510(k)

Rusch Latex Gold Foley Catheter

K-Number: K262056 · 2026-08-05

ApplicantTeleflex Medical Sdn. Bhd.
Decision Date2026-08-05
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch Latex Gold Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K262056. 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 Latex Gold Foley Catheter?

Rusch Latex Gold Foley Catheter is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Teleflex Medical Sdn. Bhd.. The 510(k) number is K262056.

When did Rusch Latex Gold Foley Catheter receive FDA 510(k) clearance?

Rusch Latex Gold Foley Catheter received FDA 510(k) clearance on 2026-08-05, under 510(k) number K262056.

Who is the listed applicant for Rusch Latex Gold Foley Catheter?

The FDA 510(k) record lists Teleflex Medical Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Rusch Latex Gold Foley Catheter is EZL.

Other records listing Teleflex Medical Sdn. Bhd. 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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledK252537Rusch SoftSimplastic Foley Catheters

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.

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, LLCK233411Folysil Silicone CatheterColoplast Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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