SpyGlass DS And DS II Direct Visualization System

Choledochoscope And Accessories, Flexible/rigid

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyglass Ds And Ds Ii Direct Visualization System.

Pre-market Notification Details

Device IDK181439
510k NumberK181439
Device Name:SpyGlass DS And DS II Direct Visualization System
ClassificationCholedochoscope And Accessories, Flexible/rigid
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactCarter Navarro
CorrespondentJennifer Kimball
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeFBN  
Subsequent Product CodeKQM
Subsequent Product CodeNTN
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-01
Decision Date2018-08-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.