FDA.reportPublic FDA data

510(k) K221784

Device
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K221784
Product code
FBN
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-16
Date received
2022-06-21
Regulation
876.1500
Classification name
Choledochoscope And Accessories, Flexible/Rigid
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 FBN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K161147EndoCure Model EUR078AEndocure Technologies, Inc.2016-06-07