Cleared Traditional

Synapsys VHIT

K242726 · Inventis S.R.L. · Ear, Nose, Throat

Jan 2025

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K242726 is an FDA 510(k) clearance for the Synapsys VHIT, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Inventis S.R.L. (Padova, IT). The FDA issued a Cleared decision on January 3, 2025, 115 days after receiving the submission on September 10, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K242726 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2024
Decision Date	January 03, 2025
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF