FDA 510(k)

TP Pivot Pro Needle Guide

K-Number: K233109 · 2023-12-22

Decision Date2023-12-22

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TP Pivot Pro Needle Guide is a medical device manufactured by Civco Medical Solutions. It received FDA 510(k) clearance on 2023-12-22 under approval number K233109. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TP Pivot Pro Needle Guide?

TP Pivot Pro Needle Guide is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Civco Medical Solutions. The 510(k) number is K233109.

When was TP Pivot Pro Needle Guide approved by the FDA?

TP Pivot Pro Needle Guide received FDA 510(k) clearance on 2023-12-22, under approval number K233109.

What company makes TP Pivot Pro Needle Guide?

TP Pivot Pro Needle Guide is manufactured by Civco Medical Solutions.

What is the FDA product code for TP Pivot Pro Needle Guide?

The FDA product code for TP Pivot Pro Needle Guide is ITX.

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Related Devices (Code: ITX)

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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.