FDA.reportPublic FDA data

510(k) K240675

Device
Endoscopic Injection Needles
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
510(k) number
K240675
Product code
FBK
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-04
Date received
2024-03-11
Regulation
876.1500
Classification name
Endoscopic Injection Needle, Gastroenterology-Urology
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
Yang Zearou
Address
# 1388 Cangxing St., Cangqian Community,Yuhang District Hangzhou City CN 311121 311121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FBK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.2026-03-31
K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.2025-12-02
K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation2025-10-16
K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.2025-02-27
K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.2024-08-27
K232200Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd.2024-04-12
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K232442Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd.2023-11-09
K230925Disposable Injection Needle AF seriesAlton (Shanghai) Medical Instruments Co., Ltd.2023-09-27
K222006Sclerotherapy & Endoscopic NeedlesG-Flex Europe Sprl2023-04-03
K221054CORE-INJECTORIncore Co., Ltd.2022-12-21
K221085LiNA OperaScope NeedleLina Medical Aps2022-09-02
K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-08-19
K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd.2022-07-29
K213239Endoscopic Injection NeedleBeijing Zksk Technology Co., Ltd.2022-06-02