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FDA 510(k)

Disposable Intermittent Catheter (TPU Catheter)

K-Number: K243175 · 2025-06-26

ApplicantChengdu Daxan Innovative Medical Tech. Co., Ltd.
Decision Date2025-06-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Intermittent Catheter (TPU Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243175. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Intermittent Catheter (TPU Catheter)?

Disposable Intermittent Catheter (TPU Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The 510(k) number is K243175.

When did Disposable Intermittent Catheter (TPU Catheter) receive FDA 510(k) clearance?

Disposable Intermittent Catheter (TPU Catheter) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243175.

Who is the listed applicant for Disposable Intermittent Catheter (TPU Catheter)?

The FDA 510(k) record lists Chengdu Daxan Innovative Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Intermittent Catheter (TPU Catheter)?

The FDA product code for Disposable Intermittent Catheter (TPU Catheter) is EZD.

Other records listing Chengdu Daxan Innovative Medical Tech. Co., Ltd. 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.

K212567PVC Hydrophilic Urethral Catheter

Related Devices (Code: EZD)

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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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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