FDA.reportPublic FDA data

510(k) K232969

Device
Disposable Hemostatic Clips
Applicant
Ningbo Xinwell Medical Technology Co., Ltd.
510(k) number
K232969
Product code
PKL
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-07
Date received
2023-09-21
Regulation
876.4400
Classification name
Hemostatic Metal Clip For The Gi Tract
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
Lei Xi
Address
#188 Binjiang Rd., Cixi High-Tech Industrial Development Zone Ningbo Cixi CN 315301 315301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PKL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.2026-05-21
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K241858BARS Set (100.60)Ovesco Endoscopy AG2024-08-26
K234124Single Use HemoclipsPromisemed Hangzhou Meditech Co., Ltd.2024-07-12
K240617Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.2024-06-03
K233772Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd.2024-03-19
K232450Disposable Hemostatic ClipsZhejiang Soudon Medical Technology Co., Ltd.2024-01-26