TX1 TISSUE REMOVAL SYSTEM— 510(k) K123640

Substantially Equivalent

Tenex Health

FDA 510(k) clearance K123640 for TX1 TISSUE REMOVAL SYSTEM, Substantially Equivalent on 2013-03-20. Applicant: Tenex Health.

Clearance details

Applicant: Tenex Health
Product code: Code LFL
Advisory panel: Unknown
Date received: 2012-11-26
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest,, CA, US

Download summary PDF View on FDA.gov ↗

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.