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FDA 510(k)

Lap-Band System Calibration Tube

K-Number: K220455 · 2022-06-07

ApplicantReshape Lifesciences
Decision Date2022-06-07
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Lap-Band System Calibration Tube is a medical device manufactured by Reshape Lifesciences. It received FDA 510(k) clearance on 2022-06-07 under approval number K220455. 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 Lap-Band System Calibration Tube?

Lap-Band System Calibration Tube is a medical device that received FDA 510(k) clearance on 2022-06-07. It is manufactured by Reshape Lifesciences. The 510(k) number is K220455.

When was Lap-Band System Calibration Tube approved by the FDA?

Lap-Band System Calibration Tube received FDA 510(k) clearance on 2022-06-07, under approval number K220455.

What company makes Lap-Band System Calibration Tube?

Lap-Band System Calibration Tube is manufactured by Reshape Lifesciences.

What is the FDA product code for Lap-Band System Calibration Tube?

The FDA product code for Lap-Band System Calibration Tube is KNT.

Related Clinical Trials

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Other Devices by Reshape Lifesciences

K221898Gastrointestinal Boundary Identifier (GIBI HD) K230131ReShape Calibration Tubes K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

Related Devices (Code: 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.

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