# K211529: NAVIRFA Scope

- Pathway: 510(k) (Traditional)
- Applicant: Navifus Corporation
- Decided: May 5, 2022 after 353 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K882383 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141806: Clear Guide One, Clear Guide Medical (2014) Summary page 4.

## Indications for use
The NAVIRFA Scope is intended to provide physicians with the trajectory information of needle instruments when used in conjunction with medical ultrasound. Instruments used with the NAVIRFA Scope may include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in needle interventional procedures that already use ultrasound devices for visualization. The device is intended for prescription use only.

Source page: https://510kreport.com/device/K211529
Methodology: https://510kreport.com/methodology