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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 the device name listed in this FDA 510(k) record. The listed applicant is Rafael Medical Devices, LLC. It received FDA 510(k) clearance on 2024-12-11 under 510(k) 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. The listed applicant is Rafael Medical Devices, LLC. The 510(k) number is K242417.

When did VECTR – Video Endoscopic Carpal Tunnel Release System receive FDA 510(k) clearance?

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

Who is the listed applicant for VECTR – Video Endoscopic Carpal Tunnel Release System?

The FDA 510(k) record lists Rafael Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02514317Percutaneous Treatment of Carpal Tunnel Syndrome With ScanCOMPLETEDNCT04811287PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel SyndromeTERMINATEDNCT07692074Minimally Invasive Retrograde Carpal Tunnel Release Using the KeriKnife™ Under Direct VisualizationNOT_YET_RECRUITING

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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