# K971582: Nipro Coreless Needle/Coreless Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Dec 22, 1997 after 236 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895769 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895769: Exel Huber Needle, Exel Intl. (1990) Summary page 1.
- K895770: Exel Huber Infusion Set, Exel Intl. (1990) Summary page 1.

## Indications for use
The Nipro Coreless Needle and the Nipro Coreless Needle Set, for which coring is prevented, are intended to be used to inject a drug solution into a reservoir implanted in the body.

Source page: https://510kreport.com/device/K971582
Methodology: https://510kreport.com/methodology