Cleared Traditional

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH

K130357 · Covidien, LLC · Ear, Nose, Throat
Nov 2013
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K130357 is an FDA 510(k) clearance for the SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH, a Brush, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BTG), submitted by Covidien, LLC (Plymouth, US). The FDA issued a Cleared decision on November 6, 2013, 266 days after receiving the submission on February 13, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number K130357 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2013
Decision Date November 06, 2013
Days to Decision 266 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code BTG — Brush, Biopsy, Bronchoscope (non-rigid)
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).

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