# K171348: Pinpoint GT Needle Guide Kits

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 22, 2017 after 14 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: 3 generations back to K844472 (1985). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042445: Site-Rite Needle Guide Kits and Probe Cover Kit, Bard Access Systems, Inc. (2004) Summary page 4.

## Most influential descendants
- K250469: Accuro® 3S Needle Guide Kit (2025), 1 descendant of its own
- K261014: Accuro® 3S Needle Guide Kit (2026), 0 descendants of its own

## Indications for use
Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems. Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.

Source page: https://510kreport.com/device/K171348
Methodology: https://510kreport.com/methodology