Gastrointestinal Boundary Identifier (GIBI HD)
K-Number: K221898 · 2022-07-28
ApplicantReshape Lifesciences
Decision Date2022-07-28
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Gastrointestinal Boundary Identifier (GIBI HD) is a medical device manufactured by Reshape Lifesciences. It received FDA 510(k) clearance on 2022-07-28 under approval number K221898. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gastrointestinal Boundary Identifier (GIBI HD)?
Gastrointestinal Boundary Identifier (GIBI HD) is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Reshape Lifesciences. The 510(k) number is K221898.
When was Gastrointestinal Boundary Identifier (GIBI HD) approved by the FDA?
Gastrointestinal Boundary Identifier (GIBI HD) received FDA 510(k) clearance on 2022-07-28, under approval number K221898.
What company makes Gastrointestinal Boundary Identifier (GIBI HD)?
Gastrointestinal Boundary Identifier (GIBI HD) is manufactured by Reshape Lifesciences.
What is the FDA product code for Gastrointestinal Boundary Identifier (GIBI HD)?
The FDA product code for Gastrointestinal Boundary Identifier (GIBI HD) is KNT.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.