# K972672: Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Barzell-Whitmore Maroon Bells, Inc.
- Decided: Jul 29, 1997 after 13 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
Longest line of descent: 1 generation back to K850571 (1985). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905198: Diagnostic Ultrasound System Type 3535, Bruel & Kjaer (1991) Summary page 2.
- K914945: Diagnostic Ultrasound System Type 3535, Modified, Bruel & Kjaer Industri A/S (1992) Summary page 2.
- K875241: Civco Seed Implant Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) Summary page 2.
- K850571: I-125 Implant Gun, Mick Radio-Nuclear Instruments, Inc. (1985) Summary page 2.
- (no number) Civco Ultra-Step: named in the summary without a submission number
- (no number) Ultra-Step Ultrasound Probe/Stepper Fixation Device: named in the summary without a submission number

## Most influential descendants
- K131161: EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation, (2013), 1 descendant of its own
- K982696: Interplant (1999), 1 descendant of its own
- K171040: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (2017), 0 descendants of its own
- K131428: Radvision (2013), 0 descendants of its own
- K023430: UF Brachytherapy Stand (2003), 0 descendants of its own

## Indications for use
This device is indicated for use in adult males with known or suspected prostate cancer.

Source page: https://510kreport.com/device/K972672
Methodology: https://510kreport.com/methodology