# K052048: Accordion

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Incorporated
- Decided: Sep 13, 2005 after 46 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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) SLIP Urology Introducer Sheath: named in the summary without a submission number
- (no number) Stone Cone Nitinol Urological Retrieval Coil: named in the summary without a submission number
- (no number) Movable Core Guidewire: named in the summary without a submission number

## Most influential descendants
- K172299: Accordion Piccolo Stone Management Device (2017), 0 descendants of its own
- K113692: XENX (2012), 0 descendants of its own
- K102887: Accordion Stone Management Device Model AC281205 and AC3814510 (2011), 0 descendants of its own

## Indications for use
The ACCORDION Urological Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

Source page: https://510kreport.com/device/K052048
Methodology: https://510kreport.com/methodology