# K001563: Scipro (TM) Flexible Stone Dislodger and Retrieval Set

- Pathway: 510(k) (Traditional)
- Applicant: Scion Cardiovascular, Inc.
- Decided: Nov 22, 2000 after 187 days
- Product code: FGO (Dislodger, Stone, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4680
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 30, 2003 · Not classified · Z-0557-04: The firm received field complaints that it was difficult to open the stone retrieval basket during use.
- May 23, 2003 · Not classified · Z-0554-04: Possible difficulty for the user in opening the stone retrieval basket.

Source page: https://510kreport.com/device/K001563
Methodology: https://510kreport.com/methodology