# K053245: GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter; Biliary Catheter

- Pathway: 510(k) (Special)
- Applicant: Uresil, LLC
- Decided: Dec 20, 2005 after 29 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200103: BIOTEQ Drainage Catheter Set (One Step Type) (2020), 3 descendants of its own
- K210419: BIOTEQ Drainage Catheter BT-PDS-series (2022), 2 descendants of its own
- K254179: Drainage Catheter (2026), 0 descendants of its own
- K251019: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (2025), 0 descendants of its own

## Indications for use
For percutaneous drainage of abscesses, nephrostomy and other fluids.

Source page: https://510kreport.com/device/K053245
Methodology: https://510kreport.com/methodology