TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE— 510(k) K121264

Substantially Equivalent

Medtronic Surgical Technologies

FDA 510(k) clearance K121264 for TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE, Substantially Equivalent on 2012-08-27. Applicant: Medtronic Surgical Technologies.

Clearance details

Applicant: Medtronic Surgical Technologies
Product code: Code HBE
Advisory panel: Neurology
Date received: 2012-04-26
Decision date: 2012-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.