TP Pivot Pro™ Needle Guide

FDA 510(k) K233109 · Civco Medical Solutions

Substantially Equivalent

510(k) numberK233109

Submission

Device name
TP Pivot Pro™ Needle Guide
Applicant
Civco Medical Solutions
Kalona, IA, US
Received
September 27, 2023
Decision date
December 22, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was TP Pivot Pro™ Needle Guide cleared by the FDA?

TP Pivot Pro™ Needle Guide (K233109) received a 510(k) decision of Substantially Equivalent on December 22, 2023, 86 days after the submission was received.

What is the product code of K233109?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.