RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET— 510(k) K122235

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K122235 for RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET, Substantially Equivalent on 2013-09-06. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2012-07-26
Decision date: 2013-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.