Cleared Traditional

ORiGO System

K213697 · Bien-Air Surgery SA · Neurology
Oct 2022
Decision
342d
Days
Class 2
Risk

About This 510(k) Submission

K213697 is an FDA 510(k) clearance for the ORiGO System, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on October 31, 2022, 342 days after receiving the submission on November 23, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K213697 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2021
Decision Date October 31, 2022
Days to Decision 342 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360

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