FDA.reportPublic FDA data

510(k) K222677

Device
Intermittent nelaton catheter for single use
Applicant
Hangzhou Jimushi Meditech Co., Ltd.
510(k) number
K222677
Product code
EZD
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-05
Date received
2022-09-06
Regulation
876.5130
Classification name
Catheter, Straight
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Fenlong Wu
Address
Bldg. 1, # 12 Longtan Rd., Cangqian St. Yuhang District Hangzhou CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EZD#

510(k), Device, Applicant table
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K251116Luja CoudéColoplast Corp.2025-06-27
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K241210Luja CoudeColoplast Corp.2024-11-21
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