Cleared Traditional

K082634 - VERTIGONE BPPV GOGGLE

K082634 · Vertigone, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
209d
Days
-
Risk

K082634 is an FDA 510(k) clearance for the VERTIGONE BPPV GOGGLE. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Vertigone, Inc. (Woodlands, US). The FDA issued a Cleared decision on April 7, 2009 after a review of 209 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Vertigone, Inc. devices

FDA 510(k) Submission Details - K082634

510(k) Number K082634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2008
Decision Date April 07, 2009
Days to Decision 209 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 89d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -