Tenex Health TX System with the TXP MicroTip— 510(k) K181367

Name: FDA 510(k) clearance K181367
Creator: U.S. Food and Drug Administration
Published: 2018-08-28

Substantially Equivalent

Tenex Health, Inc.

FDA 510(k) clearance K181367 for Tenex Health TX System with the TXP MicroTip, Substantially Equivalent on 2018-08-28. Applicant: Tenex Health, Inc.. Device class: Unclassified.

Clearance details

Applicant: Tenex Health, Inc.
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-05-23
Decision date: 2018-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest,, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.