Cleared Traditional

K083720 - OSSEODUO

K083720 is an FDA 510(k) clearance for OSSEODUO, manufactured by Bien-Air Surgery SA. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K083720 · Bien-Air Surgery SA · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
95d
Days
Class 2
Risk

K083720 is an FDA 510(k) clearance for the OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on March 20, 2009 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat device framework. 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 Bien-Air Surgery SA devices

FDA 510(k) Submission Details - K083720

510(k) Number K083720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date March 20, 2009
Days to Decision 95 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
6d slower than avg
Panel avg: 89d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ERL Device Classification - Class 2, Special Controls

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 59
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K083720.
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
K131053 · The Anspach Effort, Inc. · Dec 2013
DTAD
K121678 · Gyrus Acmi, Inc. · Aug 2012
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K112593 · Stryker Corporation · May 2012
REPROCESSED ENT SHAVERS
K081814 · Sterilmed, Inc. · Dec 2008
STRYKER ESSX WITH NAVIGATION MOUNT
K080052 · Stryker Corp. · Oct 2008
PRIMADO SURGICAL DRILL
K080722 · Nakanishi, Inc. · Sep 2008