K-number	K233109
Device name	TP Pivot Pro Needle Guide
Applicant	Civco Medical Solutions
Product code	ITX
Device class	Class II
Decision date	Dec 22, 2023
Decision	Substantially Equivalent
Regulation	892.1570

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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TP Pivot Pro Needle Guide

Everything you need for a 510(k) submission. Nothing you don't.

TP Pivot Pro Needle Guide