# K171040: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: Jul 31, 2017 after 116 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: 6 generations back to K850478 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093713: Ultrasound General Purpose Guidance System, Civco Medical Instruments (2010) Summary page 4.
- K131161: EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation,, CIVCO Medical Instruments Co., Inc. (2013) Summary page 4.

## Indications for use
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions. I. Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment. l.a. CON-LEAD range and LIN-LEAD range The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment. 1.b. PERINE range The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males. 2. Steady Pro range The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.

Source page: https://510kreport.com/device/K171040
Methodology: https://510kreport.com/methodology