Cleared Traditional

OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece

K143492 · Bien-Air Surgery SA · Ear, Nose, Throat

Mar 2015

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K143492 is an FDA 510(k) clearance for the OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece, 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 March 4, 2015, 86 days after receiving the submission on December 8, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K143492 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2014
Decision Date	March 04, 2015
Days to Decision	86 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