SpyGlass Discover Retrieval Basket

Dislodger, Stone, Biliary

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyglass Discover Retrieval Basket.

Pre-market Notification Details

Device IDK203322
510k NumberK203322
Device Name:SpyGlass Discover Retrieval Basket
ClassificationDislodger, Stone, Biliary
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01749
ContactLindsay Forys
CorrespondentLindsay Forys
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01749
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2021-05-26

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