# K180029: Malecot Nephrostomy Catheter/Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 21, 2018 after 261 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K924608 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System, Boston Scientific Corp (2014) Summary page 4.
- K140085: Universa Percultaneous  Drainage Catheter, Cook Incorporated (2014) Summary page 4.

## Indications for use
The Malecot Nephrostomy Catheter/Stent Set is intended for use as a nephrostomy drainage catheter and ureteral stent. The catheter is placed percutaneously through an existing nephrostomy tract.

Source page: https://510kreport.com/device/K180029
Methodology: https://510kreport.com/methodology