510(k) · Cleared

Cleared

Northwest Radiation Therapy Products, Precision Stepper and Guide

K973786510(k) TraditionalCleared Jan 2, 199888-day reviewClass I21 CFR 892.5650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nw Radiation Therapy Products · IWJ System, Applicator, Radionuclide, Manual

Cleared on Jan 2, 1998 as substantially equivalent to K875241 (CIVCO Medical Instruments Co., Inc., 1988) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1987.

Decided: Jan 2, 1998
Review: 88 days
Class: Class I
Product code: IWJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K871413 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK871413 Civco StepperCIVCO Medical Instruments Co., Inc. · 1987
This deviceK973786 Northwest Radiation Therapy Products, Precision Stepper and GuideNw Radiation Therapy Products · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871413	Civco Stepper	CIVCO Medical Instruments Co., Inc.	1987	—
0 (this device)	K973786	Northwest Radiation Therapy Products, Precision Stepper and Guide	Nw Radiation Therapy Products	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

FIG. 1 — Lineage of K973786, 1987–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K875241	Civco Seed Implant Needle Guide Summary page 1 …s Precision Stepper and Needle Guide Manual Radionuclide Applicator System 21 CFR 892.5650; Product Code IWJ Class 1 (Radiology Panel) CIVCO Seed Implant Needle Guide (K875241) CIVCO Ultra-Step Stepper (K871413) The Precision Stepper and Needle Guide is a manually operated medical device used to provide…	CIVCO Medical Instruments Co., Inc.	1988	—
*	K871413	Civco Stepper Summary page 1 …e Manual Radionuclide Applicator System 21 CFR 892.5650; Product Code IWJ Class 1 (Radiology Panel) CIVCO Seed Implant Needle Guide (K875241) CIVCO Ultra-Step Stepper (K871413) The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the applica…	CIVCO Medical Instruments Co., Inc.	1987	—

Also cleared against K875241: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K875241.

How does its category compare?

All IWJ devices

IWJ System, Applicator, Radionuclide, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWJ

FDA has decided no IWJ device since 2007.

Median 510(k) review, days · IWJ

Too few IWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · IWJ

1in 2019

2007high 5 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IWJ

40in 2025

2007high 40 (2025) · low 0 (2007)2025

MAUDE reports naming product code IWJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	5	0
2008	—	0	3
2009	—	1	3
2010	—	0	1
2011	—	1	0
2012	—	0	0
2013	—	0	7
2014	—	0	4
2015	—	0	2
2016	—	0	2
2017	—	0	7
2018	—	2	3
2019	—	1	5
2020	—	0	5
2021	—	0	15
2022	—	0	3
2023	—	0	1
2024	—	0	2
2025	—	0	40
2026	—	0	—

What is it indicated for?

Condition to be screened, monitored, treated or diagnosed.

Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy

The Precision Stepper provides equipment support and guidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973786: Northwest Radiation Therapy Products, Precision Stepper and Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973786

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026