# K242417: VECTR – Video Endoscopic Carpal Tunnel Release System

- Pathway: 510(k) (Traditional)
- Applicant: Rafael Medical Devices, LLC
- Decided: Dec 11, 2024 after 118 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223406: SmartRelease Endoscopic Soft Tissue Release System, Microaire Surgical Instruments (2023) Summary page 5.

## Indications for use
The VECTR — Video Endoscopic Carpal Tunnel Release System is indicated for use in minimally invasive ligament or fascia release surgeries. such as: » Carpal tunnel release in the wrist * Cubital tunnel release in the elbow

Source page: https://510kreport.com/device/K242417
Methodology: https://510kreport.com/methodology