# K050724: Sure-Point Midline Stepping and Stabilization System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 18, 2005 after 28 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Sure-Point® Midline Stepping and Stabilization System: named in the summary without a submission number

## Indications for use
The SURE-POINT MIDLINE Stepping and Stabilization System is indicated for use to allow precision ultrasound alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate cancer.

Source page: https://510kreport.com/device/K050724
Methodology: https://510kreport.com/methodology