Cleared Traditional

TruDi Curette

K201174 · Acclarent, Inc. · Ear, Nose, Throat

Aug 2020

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K201174 is an FDA 510(k) clearance for the TruDi Curette, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on August 12, 2020, 103 days after receiving the submission on May 1, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K201174 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2020
Decision Date	August 12, 2020
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.