Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set

FDA 510(k) K193133 · Cook Incorporated

Substantially Equivalent

510(k) numberK193133

Submission

Device name
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
Applicant
Cook Incorporated
Bloomington, IN, US
Received
November 12, 2019
Decision date
December 12, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOH – Tube Tracheostomy And Tube Cuff
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5800
Specialty
Anesthesiology
Life-sustaining
Yes

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K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffJOH · Traditional Covidien06/01/2020SE
K182861Shiley Neonatal/Pediatric Tracheostomy TubeJOH · Traditional Covidien03/22/2019SE
K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional Smiths Medical Asd, Inc.05/08/2018SE
K180034Weinmann Tracheostomy Exchange SetJOH · Traditional Cook Incorporated05/07/2018SE
K172720TRACOE silcosoft Tracheostomy TubeJOH · Traditional Tracoe Medical GmbH04/27/2018SE
K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeJOH · Traditional Smiths Medical Asd, Inc.12/07/2017SE
K151404ProTrach DualcareJOH · Traditional Atos Medical AB02/12/2016SE

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Questions and answers

When was Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set cleared by the FDA?

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133) received a 510(k) decision of Substantially Equivalent on December 12, 2019, 30 days after the submission was received.

What is the product code of K193133?

The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.