Cleared Traditional

Trachealator

K211894 · Disa Medinotec · Ear, Nose, Throat

Nov 2021

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K211894 is an FDA 510(k) clearance for the Trachealator, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Disa Medinotec (Johannesburg, ZA). The FDA issued a Cleared decision on November 24, 2021, 156 days after receiving the submission on June 21, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K211894 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2021
Decision Date	November 24, 2021
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).