TAUTONA INJECTOR DEVICE— 510(k) K131963

Substantially Equivalent

Tautona Group, LLC

FDA 510(k) clearance K131963 for TAUTONA INJECTOR DEVICE, Substantially Equivalent on 2013-10-22. Applicant: Tautona Group, LLC.

Clearance details

Applicant: Tautona Group, LLC
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2013-06-27
Decision date: 2013-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.