# K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: Dec 16, 2004 after 22 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K851140 (1985). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851140: Teleflex Medical Introducer Needle, Teleflexmedical, Inc. (1985) Summary page 3.
- K895024: Punctur-Guard (TM) Blood Collection Needle, Bio-Plexus, Inc. (1990) Summary page 2.
- K000665: TFX Medical Safety Needle with Introducer, Tfx Medical, Inc. (2000) Summary page 3.
- K021034: Modified TFX Medical Safety Needle with Introducer, Tfx Medical, Inc. (2002) Summary page 2.

## Most influential descendants
- K070449: Lumiloc (TM) Safety Introducer Needle (2007), 1 descendant of its own
- K211072: Safety Trocar Cannula (2021), 0 descendants of its own
- K180725: Aspire Introducer Needle (2018), 0 descendants of its own

## Indications for use
The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

Source page: https://510kreport.com/device/K043258
Methodology: https://510kreport.com/methodology