# K162769: Pinpoint GT Introducer Needle

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 4, 2016 after 32 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801941 (1980). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142445: Pinpoint GT Safety Introducer Needle, C.R. Bard, Inc. (2015) Summary page 4.

## Indications for use
The Pinpoint™ GT Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

Source page: https://510kreport.com/device/K162769
Methodology: https://510kreport.com/methodology