FDA.reportPublic FDA data

510(k) K232200

Device
Disposable Injection Needles
Applicant
Ningbo Xinwell Medical Technology Co., Ltd.
510(k) number
K232200
Product code
FBK
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-12
Date received
2023-07-25
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
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 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
K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.2024-10-04
K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.2024-08-27
K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)Steris2024-03-08
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