# K031173: Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013

- Pathway: 510(k) (Traditional)
- Applicant: Needle Tech Products, Inc.
- Decided: Jul 23, 2003 after 100 days
- Product code: GDF (Guide, Needle, Surgical)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Terumo Neolus Needle: named in the summary without a submission number
- (no number) Medtronic Disposable Hypodermic Needle Electrode: named in the summary without a submission number
- (no number) MNUL4.D Light Saber Introducer Needle: named in the summary without a submission number
- (no number) Manan Blunt Needle: named in the summary without a submission number

## Most influential descendants
- K040029: Safetynet Guidewire Introducer (2004), 1 descendant of its own
- K101312: Nuvue COLORMARK9TM) Needle (2011), 0 descendants of its own
- K073664: Frontline Medical Safetynet Guidewire Introducer (2008), 0 descendants of its own

## Indications for use
The guidewire introducer needles are intended for use as introducershnnula for percutaneous introduction and placement of guidewires in vascular procedures.

Source page: https://510kreport.com/device/K031173
Methodology: https://510kreport.com/methodology