Cleared Traditional

K220231 - GyroStim (FDA 510(k) Clearance)

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

K220231 is an FDA 510(k) clearance for the GyroStim. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K220231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -