Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Civco Medical Solutions. It received FDA 510(k) clearance on 2023-12-22 under 510(k) 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. The listed applicant is Civco Medical Solutions. The 510(k) number is K233109.

When did TP Pivot Pro™ Needle Guide receive FDA 510(k) clearance?

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

Who is the listed applicant for TP Pivot Pro™ Needle Guide?

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

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

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

Other records listing Civco Medical Solutions 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.

Related Devices (Code: ITX)

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.

Official Source

View on FDA Database →

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