# K082803: Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Inc.
- Decided: Nov 13, 2008 after 50 days
- Product code: FFL (Dislodger, Stone, Basket, Ureteral, Metal)
- Device class: 2
- Regulation: 21 CFR 876.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Accordion Urological Occluding Guidewire, Percutaneous Systems, Inc.: named in the summary without a submission number
- (no number) Open-end Ureteral Catheter, Cook Urologic: named in the summary without a submission number

## Most influential descendants
- K172299: Accordion Piccolo Stone Management Device (2017), 0 descendants of its own

## Indications for use
The Coaxial Accordion Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.

Source page: https://510kreport.com/device/K082803
Methodology: https://510kreport.com/methodology