FDA.reportPublic FDA data

510(k) K212852

Device
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K212852
Product code
ODG
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-06
Date received
2021-09-07
Regulation
876.1500
Classification name
Endoscopic Ultrasound System, 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
Cecilia Sun
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

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