FDA.reportPublic FDA data

510(k) K253139

Device
Disposable Distal Cap
Applicant
Mirco-Tech (Nanjing) Co., Ltd.
510(k) number
K253139
Product code
FBN
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-19
Date received
2025-09-25
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
N

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
K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.2026-04-03
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K222261Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.2023-04-20
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K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation2020-05-21
K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerBoston Scientific Corporation2019-01-22
K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation2018-08-23
K161147EndoCure Model EUR078AEndocure Technologies, Inc.2016-06-07