510(k) K243471

Device
Extraction Basket
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K243471
Product code
LQR
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-16
Date received
2024-11-08
Regulation
876.5010
Classification name
Dislodger, Stone, Biliary
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
He Sally
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 LQR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K173009NCompass Nitinol Stone ExtractorsCook Incorporated2017-11-07
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