Cleared Traditional

GyroStim

K220231 · Ultrathera Technologies, Inc. · Ear, Nose, Throat
Apr 2022
Decision
90d
Days
—
Risk

About This 510(k) Submission

K220231 is an FDA 510(k) clearance for the GyroStim, a Apparatus, Vestibular Analysis, submitted by Ultrathera Technologies, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on April 27, 2022, 90 days after receiving the submission on January 27, 2022. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number K220231 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2022
Decision Date April 27, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXV — Apparatus, Vestibular Analysis
Device Class —