FDA 510(k)

VUZE System

K-Number: K232976 · 2024-05-09

Decision Date2024-05-09

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VUZE System is the device name listed in this FDA 510(k) record. The listed applicant is Vuze Medical , Ltd.. It received FDA 510(k) clearance on 2024-05-09 under 510(k) number K232976. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VUZE System?

VUZE System is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Vuze Medical , Ltd.. The 510(k) number is K232976.

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

VUZE System received FDA 510(k) clearance on 2024-05-09, under 510(k) number K232976.

Who is the listed applicant for VUZE System?

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

What is the FDA product code for VUZE System?

The FDA product code for VUZE System is LLZ.

Other records listing Vuze Medical , 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.

K210830VUZE System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.