# K222705: Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Youcare Technology Co.,Ltd. (Wuhan)
- Decided: May 22, 2023 after 257 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- 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 K844090 (1984). 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)
- K183035: Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part Trocar Needle, Cook Incorporated (2019) Summary page 4.

## Indications for use
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing working access for endoscopes and surgical instruments.

Source page: https://510kreport.com/device/K222705
Methodology: https://510kreport.com/methodology