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510(k) K222354

Device
Elastic Traction System
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K222354
Product code
QSW
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-03
Date received
2022-08-04
Regulation
876.4410
Classification name
Endoscopic Traction Device
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 QSW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN220006ProdiGICovidien, LLC2022-06-13