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 360™ Ultra Clip.

Pre-market Notification Details

Device IDK193424
510k NumberK193424
Device Name:Resolution 360™ ULTRA Clip
ClassificationHemostatic Metal Clip For The Gi Tract
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactElena Hennessey
CorrespondentElena Hennessey
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodePKL  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-10
Decision Date2020-09-01
Summary:summary

Trademark Results [Resolution 360]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESOLUTION 360
RESOLUTION 360
86612707 4994533 Live/Registered
Boston Scientific Scimed, Inc.
2015-04-28
RESOLUTION 360
RESOLUTION 360
78126084 2781843 Dead/Cancelled
CYBERSONICS, INC.
2002-05-03
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