FDA 510(k)

IntraOp VSP Software Device

K-Number: K213128 · 2022-10-21

Decision Date2022-10-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IntraOp VSP Software Device is the device name listed in this FDA 510(k) record. The listed applicant is Xironetic, LLC. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K213128. 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 IntraOp VSP Software Device?

IntraOp VSP Software Device is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Xironetic, LLC. The 510(k) number is K213128.

When did IntraOp VSP Software Device receive FDA 510(k) clearance?

IntraOp VSP Software Device received FDA 510(k) clearance on 2022-10-21, under 510(k) number K213128.

Who is the listed applicant for IntraOp VSP Software Device?

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

What is the FDA product code for IntraOp VSP Software Device?

The FDA product code for IntraOp VSP Software Device is LLZ.

Related Devices (Code: LLZ)

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.

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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.