# K163437: hypodermic Pinpoint™ GT Needle

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 23, 2017 after 198 days
- Product code: PVZ (Non-Stainless Steel Needle)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K931367 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set, Bd (2002) Summary page 4.

## Indications for use
The hypodermic Pinpoint™ GT Needle is intended for the injection of medication into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection/aspiration. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.

Source page: https://510kreport.com/device/K163437
Methodology: https://510kreport.com/methodology