Cleared Traditional

K873154 - TREACE MAGNUM OTO-TOOL SYSTEM
(FDA 510(k) Clearance)

K873154 · Treace Medical, Inc. · Ear, Nose, Throat

Sep 1987

Decision

24d

Days

Class 2

Risk

K873154 is an FDA 510(k) clearance for the TREACE MAGNUM OTO-TOOL SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 4, 1987, 24 days after receiving the submission on August 11, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K873154 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 1987
Decision Date	September 04, 1987
Days to Decision	24 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