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FDA 510(k)

Rusch SoftSimplastic Foley Catheters

K-Number: K252537 · 2026-01-20

ApplicantTeleflex Medical Sdn. Bhd.
Decision Date2026-01-20
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Rusch SoftSimplastic Foley Catheters 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 2026-01-20 under 510(k) number K252537. 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 SoftSimplastic Foley Catheters?

Rusch SoftSimplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Teleflex Medical Sdn. Bhd.. The 510(k) number is K252537.

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

Rusch SoftSimplastic Foley Catheters received FDA 510(k) clearance on 2026-01-20, under 510(k) number K252537.

Who is the listed applicant for Rusch SoftSimplastic Foley Catheters?

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 SoftSimplastic Foley Catheters?

The FDA product code for Rusch SoftSimplastic Foley Catheters 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.

K262056Rusch Latex Gold Foley CatheterK252643Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

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.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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