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FDA 510(k)

TRACOE silcosoft Tracheostomy Tube

K-Number: K172720 · 2018-04-27

ApplicantTracoe Medical GmbH
Decision Date2018-04-27
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACOE silcosoft Tracheostomy Tube is the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172720. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACOE silcosoft Tracheostomy Tube?

TRACOE silcosoft Tracheostomy Tube is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K172720.

When did TRACOE silcosoft Tracheostomy Tube receive FDA 510(k) clearance?

TRACOE silcosoft Tracheostomy Tube received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172720.

Who is the listed applicant for TRACOE silcosoft Tracheostomy Tube?

The FDA 510(k) record lists Tracoe Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACOE silcosoft Tracheostomy Tube?

The FDA product code for TRACOE silcosoft Tracheostomy Tube is JOH.

Other records listing Tracoe Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203362TRACOE varioK152778TRACOE Cuff Pressure MonitorK152865TRACOE smart Cuff Manager

Related Devices (Code: JOH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTCovidien, LLCK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbHK193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidienK193133Blue 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 SetCook IncorporatedK182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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