FDA 510(k)

VECTR – Video Endoscopic Carpal Tunnel Release System

Numéro K : K242417 · 2024-12-11

Date de décision2024-12-11

Code produitHRX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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