Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)— 510(k) K260394
Substantially EquivalentHangzhou Jimushi Meditech Co., Ltd.
FDA 510(k) clearance K260394 for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR), Substantially Equivalent on 2026-06-24. Applicant: Hangzhou Jimushi Meditech Co., Ltd.. Device class: 2.
Summary
Hangzhou Jimushi Meditech's device is named "Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)." It's filed under EZD, straight catheters, and the record doesn't expand "NCR" or give sizes.
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Jimushi filed from Hangzhou, China. Review took 138 calendar days (February 6 to June 24, 2026).
Clearance details
- Applicant
- Hangzhou Jimushi Meditech Co., Ltd.
- Product code
- Product code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code EZD
view allMore clearances from Hangzhou Jimushi Meditech Co., Ltd.
view allAdverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.