ReShape Calibration Tubes
K-Number: K230131 · 2023-02-15
ApplicantReshape Lifesciences
Decision Date2023-02-15
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ReShape Calibration Tubes is a medical device manufactured by Reshape Lifesciences. It received FDA 510(k) clearance on 2023-02-15 under approval number K230131. 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 ReShape Calibration Tubes?
ReShape Calibration Tubes is a medical device that received FDA 510(k) clearance on 2023-02-15. It is manufactured by Reshape Lifesciences. The 510(k) number is K230131.
When was ReShape Calibration Tubes approved by the FDA?
ReShape Calibration Tubes received FDA 510(k) clearance on 2023-02-15, under approval number K230131.
What company makes ReShape Calibration Tubes?
ReShape Calibration Tubes is manufactured by Reshape Lifesciences.
What is the FDA product code for ReShape Calibration Tubes?
The FDA product code for ReShape Calibration Tubes 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.