# K181735: Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 27, 2019 after 268 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810368 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140085: Universa Percultaneous  Drainage Catheter, Cook Incorporated (2014) Summary page 5.
- K854909: Pediatric Percutaneous Nephrostomy Sets, Angiomed U.S., Inc. (1986) Summary page 5.

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0105-2021: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and wi
- Aug 31, 2020 · Class II · Z-0106-2021: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and wi

## Indications for use
This device is intended for percutaneous placement of a pigtail catheter in the renal pelvis for nephrostomy drainage in neonatal patients. This device is used as a nephrostomy drainage catheter and ureteral stent in pediatric patients 2 years and older.

Source page: https://510kreport.com/device/K181735
Methodology: https://510kreport.com/methodology