FDA.reportPublic FDA data

510(k) K250229

Device
Dual Action Tissue Closure Device
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K250229
Product code
PKL
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-08
Date received
2025-01-27
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
N

Applicant Contact#

Contact
Sally He
Address
# 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial Development Zone Nanjing CN 210032 210032

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
K252270HemoclipHangzhou AGS MedTech Co., Ltd.2026-04-08
K253734Taurus ClipTaurus Endoscopy2026-03-12
K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG2025-12-18
K252271HemoclipHangzhou AGS MedTech Co., Ltd.2025-11-12
K250842PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation2025-04-18
K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)Boston Scientific Corporation2025-02-06
K241005Haemostasis ClipsJiangxi Zhuoruihua Medical Instrument Co., Ltd.2025-01-02
K240274PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation2024-09-17
K241858BARS Set (100.60)Ovesco Endoscopy AG2024-08-26
K234124Single Use HemoclipsPromisemed Hangzhou Meditech Co., Ltd.2024-07-12
K232969Disposable Hemostatic ClipsNingbo Xinwell Medical Technology Co., Ltd.2024-06-07
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