# K021672: Pancreatic Drainage Tube

- Pathway: 510(k) (Traditional)
- Applicant: Aomori Olympus Co., Ltd.
- Decided: Apr 16, 2003 after 330 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
Longest line of descent: 1 generation back to K900923 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933200: Olympus PBD Stents, Olympus Corp. (1995) Summary page 1.
- K900923: Zimmon Endoscopic Pancreatic Stent, Wilson-Cook Medical, Inc. (1990) Summary page 1.

## Indications for use
This instrument has been designed to be used with Olyinpus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.

Source page: https://510kreport.com/device/K021672
Methodology: https://510kreport.com/methodology