Cleared Traditional

ORiGO System

K221184 · Bien-Air Surgery SA · Ear, Nose, Throat
Nov 2022
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K221184 is an FDA 510(k) clearance for the ORiGO System, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on November 2, 2022, 191 days after receiving the submission on April 25, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number K221184 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2022
Decision Date November 02, 2022
Days to Decision 191 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4250

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