Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)

K-Number: K260394 · 2026-06-24

ApplicantHangzhou Jimushi Meditech Co., Ltd.
Decision Date2026-06-24
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K260394. 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 Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Hangzhou Jimushi Meditech Co., Ltd.. The 510(k) number is K260394.

When did Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) receive FDA 510(k) clearance?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260394.

Who is the listed applicant for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

The FDA 510(k) record lists Hangzhou Jimushi Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

The FDA product code for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) is EZD.

Other records listing Hangzhou Jimushi Meditech 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.

K222677Intermittent nelaton catheter for single useK200134Jimushi Sterile Urethral Catheter for single use

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.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect ABK252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited

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.

↑