# K102887: Accordion Stone Management Device Model AC281205 and AC3814510

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Inc.
- Decided: May 16, 2011 after 228 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
Longest line of descent: 1 generation back to K864874 (1987). 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)
- K052048: Accordion, Percutaneous Systems, Incorporated (2005) Summary page 1.
- K864874: Segura Dretler Basket, Van-Tec, Inc. (1987) Summary page 1.

## Indications for use
The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.

Source page: https://510kreport.com/device/K102887
Methodology: https://510kreport.com/methodology