Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

Hemostatic Metal Clip For The Gi Tract

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Resolution Clip, Resolution 360 Clip, Resolution 360 Ultra Clip.

Pre-market Notification Details

Device IDK222503
510k NumberK222503
Device Name:Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
ClassificationHemostatic Metal Clip For The Gi Tract
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactJia Huang
CorrespondentJia Huang
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodePKL  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-18
Decision Date2022-09-14

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