# K183035: Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part Trocar Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 17, 2019 after 197 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: 1 generation back to K844090 (1984). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844090: Percutaneous Nephrostomy Trocar Sys, American Edwards Laboratories (1984) Summary page 6.

## Most influential descendants
- K222705: Introducer Needle (2023), 0 descendants of its own

## Indications for use
Used to establish a percutaneous tract into the renal pelvis for catheter placement or stone manipulation. Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy. Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy.

Source page: https://510kreport.com/device/K183035
Methodology: https://510kreport.com/methodology