# K160414: Precision Point Biopsy Needle Guide

- Pathway: 510(k) (Traditional)
- Applicant: Corbin Clinical Resources, LLC
- Decided: Aug 1, 2016 after 167 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: 1 generation back to K030064 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030064: Ilook 25 Needle Guide Attachment and Bracket Assembly, Sonosite,Inc. (2003) Summary page 5.

## Most influential descendants
- K233109: TP Pivot Pro™ Needle Guide (2023), 0 descendants of its own

## Indications for use
The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transrectal transducer, is to facilitate proper needle placement to access anatomical structures.

Source page: https://510kreport.com/device/K160414
Methodology: https://510kreport.com/methodology