# K090430: Backstop and Backstop Injector

- Pathway: 510(k) (Traditional)
- Applicant: Pluromed, Inc.
- Decided: Jun 2, 2009 after 103 days
- Product code: ONJ (Dissolvable Gel For Preventing Ureteral Stone Migration)
- 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: 2 generations back to K871777 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863081: 4-Wire (Carson) Stone Extractor, Cook Urological, Inc. (1986) Summary page 1.
- K970121: Stone Dislodger, Basket, Boston Scientific Corp (1997) Summary page 1.
- K013784: Ureteral Stent, Boston Scientific Corp (2002) Summary page 1.
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters, Boston Scientific Corp (1994) Summary page 1.

## Indications for use
BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.

Source page: https://510kreport.com/device/K090430
Methodology: https://510kreport.com/methodology