Tenex Health TX System with the TXP MicroTip— 510(k) K181367
Substantially EquivalentTenex 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..
Clearance details
- Applicant
- Tenex Health, Inc.
- Product code
- Code LFL
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest,, CA, US
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . 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.