# K233109: TP Pivot Pro™ Needle Guide

- Pathway: 510(k) (Traditional)
- Applicant: Civco Medical Solutions
- Decided: Dec 22, 2023 after 86 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030064 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160414: Precision Point Biopsy Needle Guide, Corbin Clinical Resources, LLC (2016) Summary page 6.

## Indications for use
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance. * Prostate - Biopsy and minimally invasive puncture. + Surgical (Prostate)- Biopsy and minimally invasive puncture.

Source page: https://510kreport.com/device/K233109
Methodology: https://510kreport.com/methodology