FDA.reportPublic FDA data

510(k) K220247

Device
Guidewire Locking Device
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K220247
Product code
ODC
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-29
Date received
2022-01-28
Regulation
876.1500
Classification name
Endoscope Channel Accessory
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
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 ODC#

510(k), Device, Applicant table
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K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation2024-02-09
K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterMedivators (A Subsidiary of Steris Corporation)2023-12-21