FDA 510(k) clearance · back to tracker

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

Hangzhou Jimushi Meditech Co., Ltd. cleared K260394 on 2026-06-24, decision: substantially equivalent

K-number

K260394

Sponsor

Hangzhou Jimushi Meditech Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-06-24

Product code

EZD

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5130

Official FDA record

Open K260394on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.