Cleared Traditional

ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

K131053 · The Anspach Effort, Inc. · Ear, Nose, Throat

Dec 2013

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K131053 is an FDA 510(k) clearance for the ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by The Anspach Effort, Inc. (Tampa, US). The FDA issued a Cleared decision on December 31, 2013, 259 days after receiving the submission on April 16, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K131053 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2013
Decision Date	December 31, 2013
Days to Decision	259 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