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FDA 510(k)

Vibrant System

K-Number: K232830 · 2023-12-08

ApplicantVibrant, Ltd.
Decision Date2023-12-08
Product CodeQTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vibrant System is the device name listed in this FDA 510(k) record. The listed applicant is Vibrant, Ltd.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232830. The device is classified under product code QTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vibrant System?

Vibrant System is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Vibrant, Ltd.. The 510(k) number is K232830.

When did Vibrant System receive FDA 510(k) clearance?

Vibrant System received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232830.

Who is the listed applicant for Vibrant System?

The FDA 510(k) record lists Vibrant, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vibrant System?

The FDA product code for Vibrant System is QTN.

Other records listing Vibrant, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223031Vibrant System

Related Devices (Code: QTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223031Vibrant SystemVibrant, Ltd.

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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