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FDA 510(k)

VECTR – Video Endoscopic Carpal Tunnel Release System

K-Number: K242417 · 2024-12-11

ApplicantRafael Medical Devices, LLC
Decision Date2024-12-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VECTR – Video Endoscopic Carpal Tunnel Release System is a medical device manufactured by Rafael Medical Devices, LLC. It received FDA 510(k) clearance on 2024-12-11 under approval number K242417. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VECTR – Video Endoscopic Carpal Tunnel Release System?

VECTR – Video Endoscopic Carpal Tunnel Release System is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by Rafael Medical Devices, LLC. The 510(k) number is K242417.

When was VECTR – Video Endoscopic Carpal Tunnel Release System approved by the FDA?

VECTR – Video Endoscopic Carpal Tunnel Release System received FDA 510(k) clearance on 2024-12-11, under approval number K242417.

What company makes VECTR – Video Endoscopic Carpal Tunnel Release System?

VECTR – Video Endoscopic Carpal Tunnel Release System is manufactured by Rafael Medical Devices, LLC.

What is the FDA product code for VECTR – Video Endoscopic Carpal Tunnel Release System?

The FDA product code for VECTR – Video Endoscopic Carpal Tunnel Release System is HRX.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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