Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini— 510(k) K170381

Substantially Equivalent

Medtronic Advanced Energy

FDA 510(k) clearance K170381 for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini, Substantially Equivalent on 2017-09-07. Applicant: Medtronic Advanced Energy.

Clearance details

Applicant: Medtronic Advanced Energy
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2017-02-07
Decision date: 2017-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portsmouth, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.