# K980917: All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Fortune Medical Instrument Corp.
- Decided: May 27, 1998 after 77 days
- Product code: GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.

Source page: https://510kreport.com/device/K980917
Methodology: https://510kreport.com/methodology