FDA 510(k)

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

K-Nummer: K260394 · 2026-06-24

AntragstellerHangzhou Jimushi Meditech Co., Ltd.

Entscheidungsdatum2026-06-24

ProduktcodeEZD

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: EZD)

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical 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).Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja SoftColoplast A.S.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated K260999LoFric Elle ProWellspect AB

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