# K982508: Flexima

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 16, 1998 after 88 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.
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. The FDA summary names its predicate without a number.
- (no number) Microvasive® Biliary Stent System: named in the summary without a submission number
- (no number) Medi-Tech® Flexima™ Biliary Drainage Catheter: named in the summary without a submission number
- (no number) Wilson-Cook® Nasal Biliary Drainage Set: named in the summary without a submission number

## Indications for use
The Flexima™ Nasobiliary Catheter is indicated for prolonged access to the biliary ductal system via the nose, including: Decompression of an obstructed bile duct in acute suppurative cholangitis. Temporary or short-term decompression of the common bile duct, similar to that which follows unsuccessful stone extraction after endoscopic sphincterotomy. Prevention of stone impaction after endoscopic sphincterotomy. Infusion of contrast medium for repeat cholangiography. Instillation of various therapeutic solutions, including antibiotics (for acute bacterial cholangitis) or saline (to flush sludge or small stones after endoscopic sphincterotomy). Preoperative biliary decompression to decrease jaundice (thereby decreasing perioperative complications) in patients undergoing elective biliary tract surgery. Temporary biliary decompression in patients who are septic or who have severe coagulopathy. Once infection has been controlled or coagulopathy corrected, sphincterotomy can be performed, and a large stent can be inserted for long-term therapy. Access for intraluminal irradiation therapy, using iridium. Aspiration of bile for chemical and bacteriologic studies (e.g., to identify causative agents in bacterial cholangitis or to determine thie lithogenicity of bile in patients with cholestasis). Facilitating the healing process in traumatic or surgical biliary fistulae.

Source page: https://510kreport.com/device/K982508
Methodology: https://510kreport.com/methodology