Gastrointestinal Boundary Identifier (GIBI HD)

Tubes, Gastrointestinal (and Accessories)

ReShape Lifesciences

The following data is part of a premarket notification filed by Reshape Lifesciences with the FDA for Gastrointestinal Boundary Identifier (gibi Hd).

Pre-market Notification Details

Device IDK221898
510k NumberK221898
Device Name:Gastrointestinal Boundary Identifier (GIBI HD)
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant ReShape Lifesciences 1001 Calle Amanecer San Clemente,  CA  92673
ContactMichelle Ravert
CorrespondentMichelle Ravert
ReShape Lifesciences 1001 Calle Amanecer San Clemente,  CA  92673
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-30
Decision Date2022-07-28

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