# K090485: Coaxial Accordion Ercp Device, Models C0AC19001, COAC20005, COAC22003

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Incorporated
- Decided: Jul 22, 2009 after 147 days
- Product code: LQR (Dislodger, Stone, Biliary)
- 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) Coaxial Accordion Stone Management Device: named in the summary without a submission number
- (no number) Fusion Extraction Balloon with Multiple Sizing: named in the summary without a submission number

## Indications for use
The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.

Source page: https://510kreport.com/device/K090485
Methodology: https://510kreport.com/methodology