# K252594: UltraGuideCTR® image guided soft tissue release system

- Pathway: 510(k) (Traditional)
- Applicant: Sonex Health
- Decided: Sep 29, 2025 after 45 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K844002 (1984). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192873: SX-One MicroKnife, Sonex Health, Inc. (2019) Summary page 5.
- K223406: SmartRelease Endoscopic Soft Tissue Release System, Microaire Surgical Instruments (2023) Summary page 5.

## Indications for use
The UltraGuideCTR® image guided soft tissue release system using real-time ultrasound visualization and guidance with integrated safety-engineered Sharps Injury Prevention is indicated for use in minimally invasive soft tissue release: * Carpal tunnel release in the wrist

Source page: https://510kreport.com/device/K252594
Methodology: https://510kreport.com/methodology