Cleared Traditional

MICRO-AIRE OTO/NEURO DRILL SYSTEM

K854331 · Micro-Aire Surgical Instruments, Inc. · Ear, Nose, Throat

Jan 1986

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K854331 is an FDA 510(k) clearance for the MICRO-AIRE OTO/NEURO DRILL SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on January 21, 1986, 85 days after receiving the submission on October 28, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K854331 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 1985
Decision Date	January 21, 1986
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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